Bioinvent International AB jobb i Lund

BioInvent ‘s activity spans all aspects of drug development, from discovery, preclinical and translational research, to manufacturing and clinical development.
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it – as our
Associate Manufacturing Scientist Upstream
We are looking for an Associate Manufacturing Scientist for our Process Development & Production Support (PDPS) team. The PDPS team are responsible for developing robust manufacturing processes and the transfer of these processes to the GMP manufacturing. The PDPS team work closely together with our GMP manufacturing team. Among others, your key responsibilities will be:
· Plan, coordinate and execute upstream process development, process optimization and process scale up activities
· Draft and revise documents such as protocols, methods, and technical plans and reports
· Support preparing regulatory submissions
· Identify, recommend, and implement emerging practices related to upstream process development and cell line development
· Interact with main stakeholders
· Support cGMP production
To succeed in this role, we believe that you have a M.Sc. in Molecular or Cellular Biology, Biotechnology or a closely related discipline.
You are fluent in spoken and written English and spoken Swedish would be an advantage.
Personal profile:
· Strong attention to detail, excellent communication skills and collaborative mindset
· Ability to adapt to rapid changes in project priorities
· Ability to learn new techniques, perform multiple tasks simultaneously, keep and accurate records
Other preferred qualifications are:
· Working in controlled aseptic environment
· Hands-on experience with mammalian cell culture techniques
· Familiarity with cGMP regulations and quality standards
We are looking for a driven, structured, self-motivated, quality conscious and responsible person, who easily collaborates and communicates with others, both verbally and in writing. You have excellent problem-solving skills, and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
The position is a full-time position based in Lund, Sweden and is currently a temporary position (until year end 2025) with possibilities for permanent employment. The working hours are mainly daytime, but the service will to some extent also be associated with certain on-call work during weekends or evenings.
BioInvent is in a unique situation with great potential to change the future. If this is your profile and you would like to contribute to changing the way cancer is treated today, you are welcome to apply for the position, we want to hear from you!
Please send us your application, personal letter and CV and tell us why you are the right person for this position, by the latest the 10th of February 2025. Interviews will be held continuously which means the positions can be filled before the deadline.

The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development. Together we are creating the exciting future of BioInvent, and we welcome you to lead our Process Development & Production Support Team.

Senior Scientist Downstream

As a Senior Scientist Downstream you are an expert in protein purification, and you will be a member of our Process Development & Production Support (PDPS) team. The PDPS team are responsible for developing robust processes and the transfer of these processes to the GMP manufacturing. The PDPS team work closely together with our GMP manufacturing team.

As Senior Scientist Downstream, your key responsibilities will include:
· Development of purification processes
· Upscaling and purification of material for toxicological studies
· Process trouble shooting
· Process transfers
· Take part in deviation investigations
· Participate in internal and external meetings
· Virus clearance studies
· Train and educate colleagues
· Write plans and reports

To succeed in this role, we believe that you have a M.Sc. chemical engineering, biochemistry, biology or closely related discipline and has +10 years’ experience from pharma/biotech industry in process development or MSAT roles.

You are fluent in spoken and written English and spoken Swedish would be an advantage.

Qualifications:
· In deep knowledge in chromatography and filtration technologies
· Experience of development of manufacturing processes for monoclonal antibodies, bi/multi specific antibodies and fusion proteins
· Knowledge in regulatory requirements for virus clearance studies
· Experience in risk-based decision making

Personal profile:

· Strong attention to detail, excellent communication skills, collaborative mindset and scientific problem-solving
· Ability to adapt to rapid changes in project priorities
· Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
· Ability to work independently and as part of a team, self-motivated, adaptable, and carry a positive attitude
The position is based at the company headquarters in Lund, Sweden.

BioInvent is in a unique situation with great potential to change the future. If this is your profile and you would like to contribute to changing the way cancer is treated today, you are welcome to apply for the position, we want to hear from you!

Please send us your application, personal letter and CV and tell us why you are the right person for this position, by the latest the 11th of November 2024. Interviews will be held continuously which means the positions can be filled before the deadline.

The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development. Together we are creating the exciting future of BioInvent, and we welcome you to be part of it – as our


Downstream Manufacturing Scientist
GMP-manufacturing group at BioInvent is responsible for supply of recombinant proteins (mainly IgGs) to our and our customers clinical trials.
As Downstream Manufacturing Scientist you are responsible for planning and running the downstream (purification) process. This include activities such as transfer of processes from development, process and production planning, generation of instructions e.g. Master Batch Records, and running the process hands in our GMP facility. Our typical processes are performed in a very limited number of batches and our production can be compared to large scale process development.

Among others, your key responsibilities will be to:
· Scaling up the purification process
· Perform protein purification: chromatography, virus reduction steps, concentration and diafiltration.
· Write process related documents: Master batch records, SOPs, Work instructions.
· Planning the purification process.
· Participate in meetings with customers
· Train and educate colleagues in Purification
· Preventive maintenance of process equipment
· Perform validation of equipment and processes
· Write plans and reports
To succeed in this role, we believe that you have a B.Sc. or M.Sc. chemical engineering, biochemistry, biology or closely related discipline.
We believe that you have the following qualifications:
· Strong attention to detail, excellent communication skills, collaborative mindset and scientific problem-solving
· Ability to adapt to rapid changes in project priorities
· Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
· Ability to work independently and as part of a team, self-motivated, adaptable, and carry a positive attitude
Other preferred qualifications are:
· Experience in working in clean room environment.
· Working in controlled aseptic environment
· Familiarity with cGMP regulations and quality standards
We are looking for a driven, structured, self-motivated, quality conscious and responsible person, who easily collaborates and communicates with others, both verbally and in writing. You have excellent problem-solving skills, and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
The position is based at the company headquarters in Lund, Sweden.
BioInvent is in a unique situation with great potential to change the future. If this is your profile and you would like to contribute to changing the way cancer is treated today, you are welcome to apply for the position, we want to hear from you!
Please send us your application, personal letter and CV and tell us why you are the right person for this position, by the latest the 28th of October 2024. Interviews will be held continuously which means the positions can be filled before the deadline.

The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development.
Regulatory Affairs Manager
As our Regulatory Affairs Manager, you will plan, author and manage the assembly and timely submission of regulatory documentation for EU, US and RoW. The role will provide strong support and guidance to cross-functional teams (across multiple projects) and CROs.
The main responsibilities are as follows:
Regulatory Affairs Manager at BioInvent is responsible for operational regulatory work executing global regulatory strategies aimed at identifying and implementing the most efficient regulatory pathways for BioInvent’s current and future drug development programs.
The responsibilities of the position include, but are not limited to:
• Responsible for coordination, development, authoring and reviews of high-quality regulatory documentation for various types of regulatory submissions (e.g., core documents for IND/CTA, incl. substantial amendments/modifications, scientific advice packages, orphan drug designation applications etc.)
• Coordinate preparation of responses to Health Authority requests for information
• Work with internal cross-functional project teams and CROs to ensure timely deliverables to regulatory strategies for any company project goals
• Oversight of CROs regarding CTR increased notification requirements and documentation redaction
• Ensure maintenance of regulatory compliance, conformance of internal quality procedures and provide training to internal stakeholders with guidance on impact of new regulatory and scientific regulations
• Support quality, regulatory, clinical and other personnel in the company as required regarding current regulatory policies and procedures.
• Take on specific tasks as a representative of the Regulatory team, in line with your individual capabilities and interests.
• Performing all duties in keeping with BioInvent’s core values, policies, and all applicable regulations.
Requirements
· At least 5 years experience in regulatory affairs in the biotech or pharmaceutical industry, with broad cross-functional regulatory knowledge in addition to special competence/interest within clinical regulatory documentation.
· Working knowledge of Regulatory legislation, worldwide, and standard documentation/ document types including understanding of GDP.
· Highly organized, proactive, and detail oriented
· Experienced communicator and facilitator
· Enjoy creating and participating in an efficient cross functional working environment
· Effective time manager
· Good organization and problem-solving skills
· Proficient in MS Word, Excel, Power Point, Outlook
· Good technical writing and editing skills
· Proficient in written and spoken English
Qualifications
· Educated to MSc level in a relevant science discipline.
· Regulatory affairs experience including assisting in the developing regulatory submission documents and coordinating delivery to submission plans, usually demonstrated by 5+ year exposure
Reporting to: Senior VP Regulatory Affairs
Personal Profile
We are looking for a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent problem solving, and negotiation skills and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Personal suitability is of great importance, and we believe that you are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines and to secure high quality within your work. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.
Location
The position offers a flexible working arrangement.
Application
Please send your application (CV and personal letter) and tell us why you are the right person for this position. Please make sure to send in your application as soon as possible, at the latest 20th of August 2024.

BioInvent ‘s activity spans all aspects of drug development, from discovery, preclinical and translational research, to manufacturing and clinical development.
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it – as our
Business Assistant & Event Coordinator to the Clinical team
With several projects ongoing in clinical development and a number of different strategic alliances with international partners, we are looking for logistic and administrative Alliance management support to ensure excellent relationships and highest level of execution of meetings and exchanges with all our partners and stakeholders, including key opinion leaders, clinical investigators, clinical research organizations, and strategic partners.
The main responsibilities are to provide support for the management of all ongoing Alliances and Clinical partnerships making sure that BioInvent entertains the best possible relationships with its partners.
The tasks will include:
· Organization of all logistic and administrative aspects of scientific events such as KOL meetings, meetings with clinical investigators, meetings with CROs, or other established or potential partners.
· Maintaining up-to-date documentation -most importantly graphic, Word documents and PowerPoint presentations- of all clinical projects to ensure timely and effective communication with partners and other stakeholders.
· Scheduling and managing the agenda of Project team meetings and Joint Steering committees with all partners to ensure compliance with BioInvent’s contractual obligations.
Other important tasks in this role are to:
· Provide overall administrative support to the clinical team to ensure neat and timely delivery of abstract, posters, and article submissions to the different meetings during the year.
· Provide overall administrative support to the clinical team, including travel coordination and calendar management of the CMO and the clinical team.
· Assisting with effective and timely onboarding process of new employees as well as with ongoing tasks and requirements for all the members of the Clinical Team for a continuous efficient business environment.
· Oversight and planning of attendance at scientific conferences, including timely registration, travel booking, abstract and poster submissions.
· Support knowledge and information filing and sharing through appropriate tools (SharePoint, Teams)
Requirements & qualifications:
To succeed in this role, we believe you have a relevant bachelor’s degree or equivalent. You need at least 5 years of relevant experience within Biotech/Pharma industry.
Personal suitability is of great importance; therefore, you also need:
· Demonstrated flexibility and professional maturity to readily understand priorities and anticipate needs.
· Ability to manage conflicting priorities and deliver the most critical assignments.
· Strong problem-solving skills, flexibility, proactivity, and reactivity.
· To be a team player and work well independently with minimal supervision.
· To be comfortable with working in a virtual team.
· Willingness to perform a wide range of tasks (“can do attitude”) including working with confidential information.
· You are enthusiastic, a kind person and enjoy creating results and achieving goals both individually and together with your teams.
· Highly proficient in the use of graphic tools, Microsoft Office including PowerPoint, Word, Outlook, and Excel; excellent written and verbal communication skills including exquisite attention to details.
The position is based at the company headquarters in Lund, Sweden, with flexibility to working from home.
BioInvent is in a unique situation with great potential to change the future. If this is your profile and you would like to contribute to changing the way cancer is treated today, you are welcome to apply for the position, we want to hear from you!
Please send us your application, personal letter and CV and tell us why you are the right person for this position, by the latest 9th of July 2024.

The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development. Together we are creating the exciting future of BioInvent, and we welcome you to be part of it - as our

Manufacturing Scientist, Downstream Process Development
We are looking for a downstream scientist with hands-on experience in purification process development for manufacture of monoclonal antibodies. The Manufacturing Scientist will provide technical and scientific leadership as subject matter expert (SME) relating to downstream manufacturing processes development, scale-down/up studies, technology implementation projects and process optimization.
Key responsibilities
As a Manufacturing Scientist, your main responsibilities will be to:
• Design and execute downstream process development activities
• Scale up and transfer of purification processes to large-scale manufacturing
• Identify, recommend and implement improvements related to routine functions
• Draft and revise documents such as SOPs, methods and technical reports
• Support regulatory submissions
• Interaction with customers

Qualifications and experiences
To succeed in this position, we think you have a M.Sc. or Ph.D. in Biochemistry, Biotechnology or closely related discipline and experience in customer relations and project planning. You need to have thorough knowledge of and hands-on experience in the following areas:
· Knowledge in purification of biologics, experience in various chromatography methods, filtration, and TFF unit operations at bench scale and pilot scale
· Experience in handling chromatography systems and familiar with the control software UNICORN
· Ability to work across multiple projects in parallel
· Experience in customer relations and project planning
In addition, experience of Bispecific & Multispecific Antibodies purification process development and virus clearance studies will be of great advantage.

Skills and capabilities
We are looking for a driven, structured, self-motivated, and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent problem-solving skills, and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Your attitude and personality are of great importance - you are thorough yet efficient and strongly committed to making things happen. You understand the importance of achieving results, being flexible and adjusting to our processes, keeping deadlines, and securing the highest quality of your work. You are enthusiastic and enjoy achieving goals both individually and jointly with your colleagues.
Other information
The position is a full-time position based in Lund, Sweden. The working hours are mainly daytime, but the service will to some extent also be associated with certain on-call work during weekends or evenings.
Application
If you match the described profile and are excited to contribute to BioInvent’s important cancer research journey, we welcome you to apply for this position. Please make sure to send in your application (CV and personal letter) as soon as possible, at the latest the 16th of September 2023.

The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it – as our
Safety & PV Manager – Clinical Development
As our Safety & PV Manager you will contribute and support aspects of clinical studies and maintain comprehensive knowledge of Drug Safety and Pharmacovigilance in drug development.
The Safety & PV Manager is responsible for providing structured and detail-oriented day to day activities pertaining to product safety and pharmacovigilance in clinical development, ensuring appropriate safety assessments and surveillance, compliant regulatory authority reporting, development and implementation of risk management strategies, and communication of safety information.
The main responsibilities are to:
- Lead the SAE/SUSARs processing, exercise judgement and apply knowledge in assessing the events and generate appropriate queries in collaboration with medical team and support regulatory reporting
- Directly oversees the CROs Drug Safety activities to ensure that they fulfill their accountabilities and responsibilities
- Support SAE Reconciliation activities for all ongoing trials
- Organize and lead ongoing safety data review such as signal detection, aggregate safety reporting, benefit-risk evaluation, risk management and mitigation plans for clinical programs
- Lead or contribute to development of DSUR, RMP, PBRER, RSI, Annual Safety Report and contribute to safety sections of relevant documents
- Up to date on literature review on Product Safety in relevant therapeutic area when pertinent to products
- Collaborate with flexibility in cross-functional teams and/or CROs
- Ensure compliance with SOPs and regulatory requirements. Formulate and implement improvements as needed.
- Contributing to Safety related meetings such as Safety Committee meeting, Cohort Review Meeting and/or Data Monitoring Committee
- Ensure compliance with ICH-GCP and support the team in maintaining a clinical Quality Management System.
Essential for the role
To succeed in this opportunity, you will have an accredited master’s or higher degree in life sciences or healthcare field, such as pharmacist, nurse, or scientist with relevant pharmacovigilance experience. A qualification/experience in oncology/hematology is an advantage. You must have at least 3-4 years clinical development experience in the biotech or pharmaceutical industry.
Desirable for the role
· Working knowledge of ICH/GCP Guidelines, FDA, EMA and other regulatory requirements; MedDRA and WHO_DRUG dictionaries
· Experience in SAE case processing and working with safety databases.
· Proven knowledge of GCP, GDP and GVP
· Proficient in MS Office, and other necessary IT tools
· Excellent written and verbal communication skills; fluent in medical terminology
· Ability to multi-task and balance day-to-day drug safety activities and project work with tight timelines
· Problem-solving skills, ability to work independently and in a collaborative team setting
· Proficient in written and spoken English
· Comply with BioInvent policies, instructions and training requirements

Personal suitability is of great importance. You are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines while securing high quality deliverables. You are enthusiastic, a kind person and enjoy creating results and achieving goals both individually and together with your teams.
The company is in Lund, Sweden. However, relocation is not a requirement for European residents.
BioInvent is in a unique situation with a great potential to change the future. If this is your profile and would like to contribute to change the way cancer is treated today, you are welcome to apply for the position, we want to hear from you!
Please send us your application, personal letter and CV and tell us why you are the right person for this new position, at the latest 4th of September. Interviews will be held continuously which means the positions can be filled before deadline.

BioInvent International AB (OMXS: BINV) is a clinical stage company focused on the development of novel, first-in-class immuno-modulatory antibodies for the treatment of cancer, addressing the need for novel treatment options that have the potential to significantly improve patient outcomes. Our powerful discovery engine is based on our validated, proprietary F.I.R.S.T™ technology and our proprietary n-CoDeR® antibody library to simultaneously identify targets and antibodies that bind to these targets, generating many promising new drug candidates to fuel the Company’s proprietary product pipeline as well as for licensing and partnering purposes.
The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it – as our
Competitive Intelligence Manager
As an information expert you will provide strategic competitive intelligence to a diverse set of internal stakeholders, making you an authority on innovative use of information and data to help shape our trials, strategy decision making, portfolio, and business partnerships. You will use a variety of information sources such as scientific literature, patent database searches, competitive intelligence, industry databases, as well as attendance at relevant global industry conferences to compile and track industry trends, competing programs and important regulatory announcements. You will produce both regular as well as ad hoc reports for internal stakeholders to address their analysis needs and will be capable of rapid analysis of competitor news flow, ensuring stakeholders are well informed of developments in the external environment. You will be the internal expert on information sources and data analytics. Working closely with the CBO, you will track the evolution of key companies and will support the business development and partnering strategies and processes.
The Competitive Intelligence Analyst has significant business impact, directly and indirectly contributing to both R&D strategy and decision-making. The individual leads the monitoring and reporting of competitor activities and industry trends which are critical in ensuring that competitive focus and awareness is embedded into BioInvent culture.
The role has high visibility and offers the opportunity to connect with a range of internal stakeholders including: the Chief Business Officer, Chief Scientific Officer, Chief Medical Officer, Director Intellectual Property, Senior Director Investor Relations, and the Chief Operating Officer. Clear written and verbal communication is therefore critical.
Essential for the role
To succeed in this opportunity, you will have a real passion for oncology, immuno-oncology, scientific and clinical data, and information – in particular knowing what information you require, how to seek it out, and how to share it with the teams in an insightful way.
In addition, you will also have:
Advanced degree in Life Science (PhD, PharmD, MD, but Masters’ degrees will also be considered)
Deep understanding of the pharmaceutical clinical drug development process
Experience in Oncology/Immuno-Oncology biology, or immunology or oncology related disciplines
Demonstrable aptitude for analytical thinking, with a methodical approach to producing detailed and accurate work
Strong capability in using data management tools such as Excel
Strong ability to produce high-level syntheses of complex information
Good communication and interpersonal skills
Strong organizational skills with the ability to multitask, set priorities and follow a timeline

Desirable for the role
Experience in defining and executing literature and database search strategies
Significant experience / proven track record in the application of information and knowledge management in a clinical, scientific, or regulatory setting
Previous experience in a competitive intelligence role in the pharmaceutical industry

Personal suitability is of great importance, and we believe that you are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines while securing high quality deliverables. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.
The company is in Lund, Sweden but relocation is not a requirement for European residents.
To summarize, BioInvent has several value driving factors in place with great potential for the future. If you match the described profile and would like to contribute to important cancer research as a part of BioInvent and our exciting future, you are welcome to apply for the position!
Please send us your application, personal letter and CV and tell us why you are the right person for this new position, at the latest 20th of December 2022.

The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development. Together we are creating the exciting future of BioInvent, and we welcome you to be part of it - as one of our

Manufacturing Senior Scientist, Upstream Process Development
We are looking for a senior scientist with hands-on experience in upstream process development for manufacture of monoclonal antibodies. This position sits in Manufacturing group which is placed in the Division of Technical Operations responsible for all CMC related activities including process development, manufacturing QA and QC. Technical Operations are involved in bringing monoclonal antibodies from DNA to Drug Substance to support clinical trials both in internal and customer projects.
Key responsibilities
As a Manufacturing Senior Scientist, your main responsibilities will be to:
· Plan, coordinate and execute upstream process development and process scale up activities
· Draft and revise documents such as protocols, methods, and technical reports
· Support preparing regulatory submissions
· Identify, recommend, and implement emerging practices related to upstream process development
· Share your expertise and be able to train and develop other team members
· Be subject matter expert during audit
· Interact with main stakeholders
Qualifications and experiences

To succeed in this position, we think you have a M.Sc. or Ph.D. in Molecular or Cellular Biology, Biotechnology or closely related discipline and experience in customer relations and project planning. You need to have thorough knowledge of and hands-on experience in the following areas:
· CHO cell culture,
· bioreactor process development,
· Upstream process scale up, and
· data analysis
In addition, cell line development experience will be a great advantage.


Skills and capabilities

We are looking for a driven, structured, self-motivated, and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent problem-solving skills, and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Your attitude and personality are of great importance - you are thorough yet efficient and strongly committed to making things happen. You understand the importance of achieving results, being flexible and adjusting to our processes, keeping deadlines, and securing the highest quality of your work. You are enthusiastic and enjoy achieving goals both individually and jointly with your colleagues.
Other information
The position is a full-time position based in Lund, Sweden. The working hours are mainly daytime, but the service will to some extent also be associated with certain on-call work during weekends or evenings.

Application
If you match above-described profile and are excited to contribute to BioInvent’s important cancer research journey, we welcome you to apply for this position. Please make sure to send in your application (CV and personal letter) as soon as possible, at the latest the 26th of June 2022.

Vi är experter på antikroppar och cancerbiologi och vi arbetar för att utveckla immunonkologiska läkemedel som påtagligt förbättrar behandlingen av cancersjukdomar och förlänger cancerpatienters liv. Vi arbetar med både forskning, produktion och kliniska försök. Vill du vara med och bidra till att skapa resultat inom forskningen mot cancer och vara en del i vår spännande framtid så är du välkommen att bli en del av vårt positiva och engagerade team. Tillsammans är vi alla med och bidrar till vår spännande framtid. och nu välkomnar vi dig att bli en del av vårt team som vår nya
Lagermedarbetare
Initialt erbjuder vi dig en visstidsanställning i ca 6 månader.
Som lagermedarbetare hos oss blir din uppgift att hantera allt förekommande arbete på vårt gående plocklager. Det är ett självständigt och ansvarsfullt arbete med högt tempo och stor variation i arbetsuppgifterna. Dina främsta arbetsuppgifter kommer att vara beställning, mottagande, uppmärkning och orderplock av varor samt beställning av transporter. Du levererar också beställda varor till våra olika avdelningar. Dokumentation, information och kommunikation, både internt och externt, är en del av ditt arbete men det är till stora delar ett fysiskt arbete vilket gör att du ska trivas med aktivitet och rörelse. Det är inte ovanligt att stegräknaren når 10 000 steg dagligen så som extra bonus är din vardagsmotion säkrad via jobbet.
Vi söker dig som har minst gymnasieexamen och erfarenhet från lagerarbete, gärna inom Life Science eller liknande bransch med motsvarande regleringar. Du trivs i en miljö där du får arbeta kvalitetsmedvetet och säkerställa att dina uppdrag och uppgifter utförs inom ramen för våra kvalitetskrav. Erfarenhet och kunskap inom GMP är en stor merit.
Du har goda skrivkunskaper i svenska för att kunna dokumentera och uppdatera olika dokument. Du har även god datorvana och kunskaper i Officepaketet. Vi arbetar på en internationell marknad vilket innebär att du även måste behärska engelska i såväl tal som skrift.
Som person är du noggrann, strukturerad och ansvarsfull och samtidigt effektiv, initiativtagande och kreativ. Personlig lämplighet är av stor betydelse och vi tror att du har ett starkt engagemang och en god samarbetsförmåga. Du förstår vikten av att uppnå resultat, hålla deadlines och säkerställa hög kvalitet inom ditt arbete. Du är entusiastisk, har en vilja att lära dig nya saker och tar initiativ till förbättringar.
Tjänsten är en heltidstjänst baserad i Lund. Arbetstiden är dagtid.
Vill du vara med och bidra till cancerforskningen som en del av BioInvent och vår spännande framtid och du dessutom passar in på beskrivningen ovan så tveka inte att skicka in din ansökan till oss!
Välkommen med din ansökan, ditt personliga brev och CV så fort som möjligt, dock senast den 6 juni. Vi kommer att träffa kandidater löpande så tjänsten kan komma att tillsättas tidigare.

Together we are creating an exciting future of BioInvent and we welcome you to be part of this journey as
Manufacturing Scientist – Purification
We are seeking a Manufacturing Scientist for Purification with hands-on experience in large-scale purification of monoclonal antibodies under GMP conditions. This position sits in downstream part of Manufacturing group which is placed in the Division of Technical Operations responsible for all CMC related activities including process development, manufacturing, QC and QA. We generate cell lines, develop processes and supply BioInvent’s clinical projects with antibodies, and additionally serve external customers as a CMO. At BioInvent we mainly use CHO cells for production and cultivate cells in single use bioreactors in sizes up to 1000L.
As our Manufacturing Scientist your Key Responsibilities will be to
· Plan, prepare and perform large scale purification of monoclonal antibodies
· Participate in small scale experiments
· Participate in tech transfer
· Draft and revise documents such as SOPs, methods and technical reports
· Interact with internal and external customers
· Be subject matter expert during audits
An important part of your role will also be to identify, recommend and implement improvements related to routine functions and to share your expertise and be able to train and develop other team members
To be successful in this role, we believe you have a minimum 3 years’ experience with large scale purification in GMP and have expertise with chromatography systems, filtration and ultrafiltration.
You also have
· Experience with ÄKTA systems and UNICORN is an advantage
· Experience with work in clean-rooms, class C and D
· Experience with LAF-work
· Documented ability to work across multiple projects in parallel
· Experience in customer relations and project planning
You need to be fluent in written and spoken English. If you understand Swedish it is an advantage.
We are looking for a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent problem-solving skills, and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Your attitude and personality are of great importance - you are thorough yet efficient and strongly committed to making things happen. You understand the importance of achieving results, being flexible and adjusting to our processes, keeping deadlines, and securing the highest quality of your work. You are enthusiastic and enjoy generating results and achieving goals both individually and jointly with your team.
If you match above-described profile and are excited to contribute to BioInvent’s important cancer research journey, we welcome you to apply for this position.
Please send your application (CV and personal letter) as soon as possible, at the latest 25th of April 2022.
Other information
The position is a full-time position based in Lund, Sweden. The working hours are flex-time and mainly day-time but occasional evening work can be expected.
The work will be a mix of desk-job and hands on work in the GMP facility and/or development laboratories. Manual work and heavy lifting may occur.
BioInvent has a collective agreement and contact persons for the Unions are Matilda Rehn, Akademikerföreningen and Jenny Nilsson, Unionenklubben.

Vi är experter på monoklonala antikroppar och cancerbiologi, och vi arbetar med att utveckla immunonkologiläkemedel som avsevärt förbättrar behandlingen av cancersjukdomar och förlänger livet för cancerpatienter. Vi arbetar med både forskning, produktion och kliniska prövningar. Tillsammans bidrar vi alla till vår spännande framtid, och vi välkomnar dig att gå med i vårt team som vår

QC Ingenjör

Vi söker en entusiastisk medarbetare till vårt QC-team. QC-laboratoriet fungerar enligt GMP (Good Manufacturing Practice) så noggrannhet är en viktig egenskap för dig. Du kommer att arbeta i en dynamisk grupp med goda möjligheter till både karriär och personlig utveckling.
Arbestuppgifter:
I arbetsuppgifterna ingår analys av monoklonala antikroppar i samband med produktion och kvalitetskontroll vid frisläppning av läkemedlet för medicinskt bruk och under stabilitetsstudier. Kalibrering och underhåll av instrument ingår också. Du planerar, trendar resultat och skriver rapporter. Deltagande som representant för QC i kundprojekt är också en del av uppgifterna.
Din profil
Du har en universitetsexamen, en lämplig bakgrund är inom kemi, biomedicinsk vetenskap eller annan relevant utbildning. Erfarenhet av GMP-aktiviteter (kvalitetskontrollerad) är ett önskvärt och erfarenhet av laboratoriearbete är ett måste. Du trivs i en miljö där du arbetar kvalitetsmedvetet, då det också ligger i ditt ansvar att se till att dina uppdrag och uppgifter utförs och dokumenteras enligt GMP.
Viktiga personliga egenskaper är ansvar, noggrannhet, flexibilitet och samarbetsförmåga. Du förstår vikten av att uppnå resultat, hålla deadlines och säkerställa hög kvalitet i ditt arbete. Du är entusiastisk, har en vilja att lära dig nya saker och tycker om att nå resultat och uppnå mål både individuellt och tillsammans med teamet. BioInvent arbetar på en internationell marknad, vilket innebär att du måste behärska engelska i tal och skrift.
Tjänsten är en heltidstjänst baserad i Lund. Arbetstiden är huvudsakligen dagtid, men är anpassad till produktionen, vilket kräver flexibilitet. Kvälls- och helgarbete kan förekomma.
Ansökan
Skicka din ansökan (CV och personligt brev) så snart som möjligt, senast den 28 mars 2022.

At BioInvent we are experts on antibodies and cancer immunology. We strive to develop first-in-class immuno-modulatory antibody-based - treatments that have significant potential to improve cancer outcome and cancer patients’ quality of life. We are based in Lund in Sweden and amongst our 90+ employees cover all parts for drug development including preclinical research, process development and GMP production and clinical trials. Together we are creating an exciting future for BioInvent and we welcome you to be part of this journey as our GMP Compliance and Validation Specialist.
We are looking for a dynamic and enthusiastic person with life science experience as a new member of our team.
GMP Compliance and Validation Specialist
As our GMP Compliance and Validation Specialist you will be a link between Technical Operations and QA, covering the compliance and validation aspects of Quality Control and Manufacturing. Our team is expanding, and you will have the possibility to influence the content of this position. The position offers a good basis for both career and personal growth.
Your responsibilities will include conducting investigations, handling changes /CAPAs and leading validation projects. As a Subject Matter Expert, you will participate in various improvement projects as well as in audits and inspections.
Your profile
To succeed in this role, you need to be a college/university graduate within Life science. Experience with GMP is a must and an understanding of compliance and/or validation is desirable.
You thrive in an environment where you get to work quality-consciously and independently. It is also in your responsibility to ensure that your assignments and tasks are carried out and documented according to GMP.
Important personal qualities are responsibility, accuracy, flexibility, and collaborative ability. You understand the importance of achieving results, meeting deadlines, and ensuring high quality in your work. You are enthusiastic, have a willingness to learn new things and enjoy reaching results and achieving goals both individually and together with the team. BioInvent works in a distinctly international market, which means that you must master spoken and written English.
Other information
The position is a full-time position based in Lund, Sweden. The working hours are daytime, but with flexibility.
Application
If you match above-described profile and are excited to contribute to BioInvent’s important cancer research journey, we welcome you to apply for this position. Please make sure to send in your application (CV and personal letter) as soon as possible, at the latest the 25th of March 2022.

BioInvent söker lagerarbetare/Warehouse Technician
Vi är experter på antikroppar och cancerbiologi och vi arbetar för att utveckla immunonkologiska läkemedel som påtagligt förbättrar behandlingen av cancersjukdomar och förlänger cancerpatienters liv. Vi arbetar med både forskning, produktion och kliniska försök. Vill du vara med och bidra till att skapa resultat inom forskningen mot cancer och vara en del i vår spännande framtid så är du välkommen att bli en del av vårt positiva och engagerade team. Tillsammans är vi alla med och bidrar till vår spännande framtid och nu välkomnar vi dig att bli en del av vårt team som vår nya lagerarbetare.
Huvudsakliga arbetsuppgifter
Som lagerarbetare hos oss innebär att du hanterar allt förekommande arbete på vårt gående plocklager. Det är ett självständigt och ansvarsfullt arbete med högt tempo och stor variation i arbetsuppgifterna. Dina främsta arbetsuppgifter kommer dock att vara beställning, mottagande, uppmärkning och orderplock av varor samt beställning av transporter. Du levererar också beställda varor till våra olika avdelningar.
Dokumentation, information och kommunikation, både internt och externt, är en del av ditt arbete men det är till stora delar ett fysiskt arbete vilket gör att du ska trivas med aktivitet och rörelse. Det är inte ovanligt att stegräknaren når 10 000 steg dagligen så som extra bonus är din vardagsmotion säkrad via jobbet.
Profil
Du har minst gymnasieexamen och gärna erfarenhet från lagerarbete inom Biotechföretag eller liknande. Du trivs i en miljö där du får arbeta kvalitetsmedvetet, då det i ditt ansvar även ligger att säkerställa att dina uppdrag och uppgifter utförs inom ramen för vår kvalitetshandbok och relevanta SOPar och andra metoder. Erfarenhet och kunskap inom GMP är krav.
Du har goda skrivkunskaper då dokumentering och uppdatering av dokument är en del av dina arbetsuppgifter. Du har även kunskaper i Officeprogram. Vi arbetar på en utpräglat internationell marknad vilket innebär att du även måste behärska engelska i såväl tal som skrift.
Som person är du noggrann, strukturerad och ansvarsfull men samtidigt effektiv, initiativtagande och kreativ. Personlig lämplighet är av stor betydelse och vi tror att du har ett starkt engagemang och en god samarbetsförmåga. Du förstår vikten av att uppnå resultat, hålla deadlines och säkerställa hög kvalitet inom ditt arbete. Du är entusiastisk, har en vilja att lära dig nya saker och tar initiativ till förbättringar.
Övrigt
Tjänsten är en heltidstjänst baserad i Lund. Arbetstiden är dagtid.
Rapporterar till Teamleader Facility & Warehouse.
Tjänsten kräver prickfritt straffregister.
Ansökan
Vill du vara med och bidra till cancerforskningen som en del av BioInvent och vår spännande framtid och du dessutom passar in på beskrivningen ovan så tveka inte att skicka in din ansökan till oss!
Välkommen med din ansökan (CV och personligt brev) via vår hemsida https://careers.bioinvent.com/ senast den 5 september 2021. Vi arbetar med löpande urval och intervjuer vilket innebär att tjänsten kan komma att tillsättas tidigare än sista ansökningsdatum så skicka gärna din ansökan så snart som möjligt.
BioInvent är medlemmar i Innovations- och kemiarbetsgivarna och följer tjänstemannaavtalet, våra fackliga kontaktpersoner är: Fredrik Wiberg, Akademikerföreningen och Jenny Nilsson, Unionenklubben.


English:
Warehouse Technician
At BioInvent, we are world experts on antibodies and tumor immunology, and we strive for developing first or best-in-class immuno-modulatory antibodies to treat cancer; new drugs that have the potential to transform cancer treatment and the quality of life of cancer patients. At BioInvent we carry out all aspects of drug development, including preclinical research, manufacturing, and clinical development. Together we are creating an exciting future for patients, for our company employees and for our investors. We welcome you to be part of it – as Warehouse Technician.
Key Responsibilities
As Warehouse Technician you handle all existing work at our warehouse. It is an independent and responsible job with a high variation in tasks. Your main tasks will however be ordering, receiving, marking and order delivery of goods as well as ordering transports. You also deliver ordered goods to our various departments. It is a is a physical work, which means that you should enjoy activity and movement, but documentation, information, and communication, both internally and externally, is also part of your work.
It is not unusual that the pedometer will count 10 000 steps a day, so as an extra bonus you will have your daily exercise done while working.
Skills and Capabilities
You have at least a gymnasium degree and preferably experience from warehouse work within biotech companies or similar. You thrive in an environment where you can work quality-consciously, as it is also your responsibility to ensure that your assignments and tasks are carried out within the framework of our quality manual and relevant SOPs and other methods. Experience and knowledge in GMP is an advantage.
You have good writing skills as documenting and updating documents is part of your duties. We work in a distinctly international market, which means that you must also master English in both speech and writing.
As a person, you are thorough, structured, and responsible but at the same time efficient, proactive, and creative. Personal suitability is of great importance, and we believe that you have a strong commitment and a good ability to work together. You understand the importance of achieving results, meeting deadlines and ensuring high quality in your work. You are enthusiastic, have a will to learn new things and take the initiative for improvements.
Other Information
The position is a full-time position based in Lund, Sweden. The working hours are mainly daytime.
Reporting to Teamleader Facility & Warehouse.
Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2021-09-05. We accept applications in both Swedish and English.
BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben

BioInvent is looking for a Control Engineer
We are experts in monoclonal antibodies and cancer biology and we are working to develop immuno-oncology drugs that significantly improve the treatment of cancer diseases and prolong the lives of cancer patients. We work with both research, production and clinical trials. We are looking for a person to work with the environmental monitoring and control of raw materials during the parental leave of our Control Engineer. The position is a 12 months full-time position, with the possibility of extension, perfect if you want to see if a job in the biotech sector is for you.
Together we all contribute to our exciting future and we welcome you to join our team as our new Control Engineer
Main tasks
Your main tasks will be to perform environmental controls of the production facility, including relevant analyses, and approving raw materials used in the production. Calibration and maintenance of instruments are also included in the tasks. You will plan, trend results and write reports. The QC laboratory works according to GMP (Good Manufacturing Practice) and accuracy is an important feature of our work. You will work in a dynamic group with good opportunities for both career and personal development.
Your profile
You are a university graduate, a suitable background is Pharmaceutical Technologist, Biomedical analyst other relevant education. Experience GMP (quality controlled) activities is a plus. Experience in microbiological methods and aseptic work is desirable. You thrive in an environment where you get to work quality-consciously, as it is also in your responsibility to ensure that your assignments and tasks are carried out and documented according to GMP.
Important personal qualities are responsibility, accuracy, flexibility, and collaborative ability. You understand the importance of achieving results, meeting deadlines, and ensuring high quality in your work. You are enthusiastic, have a willingness to learn new things and enjoy reaching results and achieving goals both individually and together with the team.
BioInvent works in a distinctly international market, which means that you must master spoken and written English.
Other
The position is a 12 months full-time position, with the possibility of extension, based in Lund. Working hours are mainly daytime, but are adapted to the production, which requires flexibility. Evening and weekend work may occur.
Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/ Interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2021-08-29.


BioInvent has a collective agreement and contact persons for the Unions are:
Elin Birgersson, Akademikerfo?reningen and Jenny Nilsson, Unionenklubben

Warehouse Technician
At BioInvent, we are world experts on antibodies and tumor immunology, and we strive for developing first or best-in-class immuno-modulatory antibodies to treat cancer; new drugs that have the potential to transform cancer treatment and the quality of life of cancer patients. At BioInvent we carry out all aspects of drug development, including preclinical research, manufacturing, and clinical development. Together we are creating an exciting future for patients, for our company employees and for our investors. We welcome you to be part of it – as Warehouse Technician.
Key Responsibilities
As Warehouse Technician you handle all existing work at our warehouse. It is an independent and responsible job with a high variation in tasks. Your main tasks will however be ordering, receiving, marking and order delivery of goods as well as ordering transports. You also deliver ordered goods to our various departments. It is a is a physical work, which means that you should enjoy activity and movement, but documentation, information, and communication, both internally and externally, is also part of your work.
It is not unusual that the pedometer will count 10 000 steps a day, so as an extra bonus you will have your daily exercise done while working.
Skills and Capabilities
You have at least a gymnasium degree and preferably experience from warehouse work within biotech companies or similar. You thrive in an environment where you can work quality-consciously, as it is also your responsibility to ensure that your assignments and tasks are carried out within the framework of our quality manual and relevant SOPs and other methods. Experience and knowledge in GMP is an advantage.
You have good writing skills as documenting and updating documents is part of your duties. We work in a distinctly international market, which means that you must also master English in both speech and writing.
As a person, you are thorough, structured, and responsible but at the same time efficient, proactive, and creative. Personal suitability is of great importance, and we believe that you have a strong commitment and a good ability to work together. You understand the importance of achieving results, meeting deadlines and ensuring high quality in your work. You are enthusiastic, have a will to learn new things and take the initiative for improvements.
Other Information
The position is a full-time position based in Lund, Sweden. The working hours are mainly daytime.
Reporting to Teamleader Facility & Warehouse.

Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2021-08-15. We accept applications in both Swedish and English.
BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben

The BioInvent team covers all parts for drug development, including preclinical research, manufacturing, and clinical development.
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it - as our Senior Clinical Quality Assurance Specialist.


Key Responsibilities
As a Senior Clinical Quality Assurance Specialist, you will be part of our QA team that is responsible for a Quality Management System for GCP and GMP.
Your responsibilities will be:
Improvement and maintenance of our clinical Quality Management System (cQMS).
Participate and conduct trial related audits, e.g. of vendors, investigational sites and internally in system and trial audits.
QA representative and provide support to clinical functions in key QMS processes, e.g. vendor selection, qualification and oversight, Change Controls, GCP and protocol deviations, CAPAs and SOPs.
Manage the clinical QMS activities and prepare status reports at Management review meetings.
Support preparation and hosting of regulatory inspections.
Support internal training on cQMS and ICH-GCP.
Interface with GMP QA e.g. in relation to BioInvent´s electronic document management system, deviation investigations, mock recalls and product complaints.
Ensure to attend and receive continuous training in relevant clinical and quality regulations and guidelines.

Requirements
In-depth knowledge of ICH-GCP
Experience in auditing (internal, external) highly desirable
Excellent verbal and written communication skills
Very good organization skills
Strong analytical and problem-solving skills
Self-motivation and independent
Efficient, risk based and solution-oriented mindset, multi-tasking, quick learner, respond to urgent needs of the team and show a strong track record of meeting deadlines.
Nurture a culture of teamwork, positive team spirit, promoting the development of each member in the team.
Knowledge and understanding of the importance of creating efficient working environment and contributing to ensure continuous improvements. Able to deal with frequent change, delays, or unexpected events.
Perform all duties in keeping with BioInvent’s core values, policies, and all applicable regulations.
Knowledge and understanding of the overall BioInvent´s key objectives and well versed in the company structure and other departments.

Qualifications:
University degree in natural sciences/engineering/quality management
At least 3 years´ experience in the biotech or pharmaceutical industry in a GCP compliant environment.

Location
The position is office based in Lund. However, the position may also offer a flexible working arrangement.
Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/ Interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2021-06-13.


BioInvent has a collective agreement and contact persons for the Unions are: Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben

At BioInvent we are experts on antibodies and cancer immunology. We strive to develop first-in-class immuno-modulatory antibody-based - treatments that have significant potential to improve cancer outcome and cancer patients’ quality of life. We are based in Lund in Sweden and amongst our 70+ employees cover all parts for drug development including preclinical research, manufacturing and clinical trials.
Together we are creating an exciting future for BioInvent and we welcome you to be part of this journey as our Team Leader in GMP Manufacturing
We are seeking a Team Leader with hands-on experience with manufacturing of antibodies. BioInvent’s manufacturing facility do produce material for drug development and are approve for production of phase I to III material. Our manufacturing is part of the drug development and do support BioInvent’s development of antibodies for use in clinical trials for treatment of cancer patients. We do also support external customers in their drug development programs and BioInvent’s international partners.
For each product we do produce a small number of batches which means that you and your team must be able to handle and react on a variety of process challenges.
You will lead a team of approx. 10 highly educated employees. The team is part of the Manufacturing group which is in the Division of Technical Operations responsible for all CMC related activities including process development, manufacturing, QC and QA. We generate cell lines, develop processes and supply BioInvent’s clinical projects with antibodies, and additionally serve external customers as a CMO. At BioInvent we mainly use CHO cells for production and cultivate cells in single use bioreactors in sizes up to 1000L.
Your primary task will be to coordinate and lead the daily work in GMP Manufacturing and to actively participate in the production process.
You will need to prioritize between competing tasks and have a close collaboration with other leaders in the matrix organization. In addition, you will also interact with our pre-clinical and clinical departments and take in task such as IND/IMP applications.
Key Responsibilities
Coordinate and lead the daily tasks in GMP Manufacturing
Troubleshoot and resolve unexpected events
Identify, recommend and implement improvements related to routine functions
Share your expertise and be able to train, motivate and develop team members
Continuously work with optimization and LEAN
Interact with customers and service providers
Draft and revise documents such as SOPs and methods
Conduct investigations and write deviations, CAPAs and Change Controls
Support preparing regulatory submissions
Participate in audits

Requirements
Experience and Qualifications
Minimum 3 years experience of leading a team of highly qualified team members
Comprehensive knowledge of cGMP, minimum 5 years of GMP experience
Experience with cell cultivation and protein purification is required
Good computer skills, experience with electronic document handling systems (knowing Veeva is an advantage)
Documented ability to work across multiple projects in parallel
Experience in customer relations and project planning
Fluent in written and spoken English. Understanding Swedish is an advantage

Skills and Capabilities
You are a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent problem-solving skills and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Your attitude and personality are of great importance - you are thorough yet efficient and strongly committed to making things happen. You understand the importance of achieving results, being flexible and adjusting to our processes, keeping deadlines and securing the highest quality of your work. You are enthusiastic and enjoy generating results and achieving goals both individually and jointly with your team.
If you match above described profile and are excited to contribute to BioInvent’s important cancer research journey, we welcome you to apply for this position.


Other information
The position is a full-time position based in Lund, Sweden. The working hours are mainly day-time and flex hours, but the position will to some extent also include support outside office hours and during weekends.
You will report to Director of Manufacturing.


Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2021-04-25


BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben

BioInvent International AB (OMXS: BINV) is a clinical stage company focused on the development of novel, first-in-class immuno-modulatory antibodies for the treatment of cancer, addressing the need for novel treatment options that have the potential to significantly improve patient outcomes. Our powerful discovery engine is based on our validated, proprietary F.I.R.S.T™ technology and our proprietary n-CoDeR® antibody library to simultaneously identify targets and antibodies that bind to these targets, generating many promising new drug candidates to fuel the Company’s proprietary product pipeline as well as for licensing and partnering purposes. More information is available at www.bioinvent.com.
The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development.
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it – as our Director Regulatory Affairs.
Key Responsibilities
The Head of Regulatory Affairs is responsible for developing and executing global regulatory strategies aimed at identifying and implementing the most efficient regulatory pathways for BioInvent’s current and future drug development programs.
The responsibilities of the position include, but are not limited to:
Developing and formulating BioInvent’s regulatory strategy and policy, ensuring that product manufacturing (CMC), pre-clinical and clinical development plans comply with all applicable regulatory requirements (e.g., global development plan, TPP).
Overseeing the planning and preparation of regulatory submissions to pursue expedited review to facilitate development of BioInvent’s drugs (e.g., IND/CTA, scientific advice, orphan drug designation, fast track designation, breakthrough designation, PRIME) and maintaining these.
Maintaining a high-quality network of service providers and consultants to bring expert critical thinking about regulatory strategy.
Acting as an internal resource for regulatory input on pre-clinical, clinical and product development (CMC) policies.
Planning, coordination and preparation of communications and interactions with regulatory agencies (e.g., scientific advice meetings, pre-IND, IND meetings) including leading the preparation of briefing documents and attending the meetings.
Supporting due diligence and partnering activities, as needed.
Analyzing and communicating current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape.
Contributing to corporate development strategies and implementation of a risk-based clinical Quality Management System.
Performing all duties in keeping with BioInvent’s core values, policies, and all applicable regulations.

Requirements
At least 10 years regulatory affairs experience in the biotech or pharmaceutical industry, preferably experience of early phase studies in oncology and /or hematology drug development. Experience with immunotherapies and monoclonal antibodies would be an advantage.
Detailed knowledgeable of European, US FDA pharmaceutical regulations and guidance, drug development process (in addition, knowledge of Chinese environment would be an advantage)
Proven ability to think strategically; managed and solved challenging regulatory issues.
Superior communication skills in cross-cultural environments
Ability to manage complexity and uncertainty.
Excellent business judgment, problem solving skills.
Enjoy creating and participating in an efficient cross functional working environment.
Be flexible, think creatively, and be willing to undertake different approaches.
Practical experience in project management and leadership.
Proficient in MS Word, Excel, Power Point, Outlook, MS Project.
Proficient in written and spoken English.
Excellent presenting skills.

Qualifications
Educated to BA/BSc level in relevant life science discipline.
Desirable: Masters/ PhD/ PharmD in related area of discipline (sciences, clinical, business, project management)


Personal Profile
We are looking for a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent problem solving, and negotiation skills and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Personal suitability is of great importance and we believe that you are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines and to secure high quality within your work. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.
To summarize, BioInvent has several value driving factors in place with great potential for the future. If you match the described profile and would like to contribute to important cancer research as a part of BioInvent and our exciting future, you are welcome to apply for the position!
Location
The position is office based in Lund. However, the position may also offer a flexible working arrangement.
Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 17 April 2021.
BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben

At BioInvent, we are world experts on antibodies and tumor immunology, and we strive for developing first or best-in-class immuno-modulatory antibodies to treat cancer; new drugs that have the potential to transform cancer treatment and the quality of life of cancer patients. At BioInvent we carry out all aspects of drug development, including preclinical research, manufacturing, and clinical development. Together we are creating an exciting future for patients, for our company employees and for our investors. We welcome you to be part of it – as a Bioreactor Specialist/Senior Scientist


The position as Bioreactor Specialist/Senior Scientist is placed in the Division of Technical Operations. Technical Operations are responsible for all CMC related activities including process development, manufacturing, QC and QA. We develop processes and supply BioInvent’s clinical projects with antibodies, and additionally serve external customers as a CMO. At BioInvent we mainly use CHO cells for production, culturing cells in single use bioreactors in sizes up to 1000L. The work is performed under GMP in classified clean rooms.


Key Responsibilities
· Producing antibodies by setting-up, operating and maintaining equipment such as bioreactors
· Adjusting equipment and process controls, calculating concentrations, dilutions and yields
· Securing robust and lean cultivation processes
· Share your expertise and be able to train and develop our cell culture team
· Equipment and process trouble shooting
· Interaction with customer
· Draft and revise documents such as SOPs, methods and technical reports
· Support IND/IMPD writings
· Identify, recommend and implement improvements related to routine functions
· Strategic technology development
· Be subject matter expert during audit
· Support to business development

Requirements
Experience and Qualifications
· Minimum 5 years of industrial, therapeutic, large scale cell culture
· Experience in handling Single Use Bioreactors
· Documented ability to work across multiple projects in parallel
· A minimum of 3 years GMP experience
· Experience in customer relations and project planning
· Fluent in written and spoken English and understand Swedish
In addition, experience from cell line development will be an advantage.


Skills and Capabilities
We are looking for a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent problem-solving skills and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Your attitude and personality are of great importance - you are thorough yet efficient and strongly committed to making things happen. You understand the importance of achieving results, being flexible and adjusting to our processes, keeping deadlines and securing the highest quality of your work. You are enthusiastic and enjoy generating results and achieving goals both individually and jointly with your team.
If you match above described profile and are excited to contribute to BioInvent’s important cancer research journey, we welcome you to apply for this position.
Other information
The position is a full-time position based in Lund, Sweden. The working hours are mainly daytime, but the service will to some extent also be associated with certain on-call work during weekends or evenings. Reporting to Director Manufacturing.


Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2021-03-15


BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben

Senior Clinical Scientist – Clinical Pharmacology
to join BioInvent’s clinical development team
At BioInvent, we are world experts on antibodies and cancer biology, and we strive for developing first or best-in-class immuno-modulatory antibodies to treat cancer; new drugs that have the potential to transform cancer treatment and the quality of life of cancer patients. At BioInvent we carry out all aspects of drug development, including preclinical research, manufacturing and clinical development.
Together we are creating an exciting future for patients, for our company employees and for our investors. We welcome you to be part of it - as a Senior Clinical Scientist.


Key Responsibilities
As a Senior Clinical Scientist, you will be part of our engaging clinical development team. You will support the development of critical and essential documents such as clinical study protocols, investigator's brochure, briefing packages, lab manuals, preclinical/clinical PK reports, and clinical study reports. You will be a point of contact for regulatory, PK/ADA, and other internal and external contributors. You will support regulatory submissions (e.g. INDs, CTAs) to European, US and other regulatory agencies. You will interact with pharmacodynamic (PD) scientists to support the development of BioInvent’s clinical drug candidates, as well as biomarker development. You will conduct literature reviews and prepare summaries to support clinical development decisions, and you will support the development of product concepts, target product profiles (TPPs), and clinical development plans for BioInvent’s drug candidates.
Requirements
MD or PhD degree or equivalent.
You have experience as a Clinical Scientist, and preferably experience of phase I/II studies in oncology and/or hematology. Knowledge about ICH-GCP and other relevant regulations to conduct clinical trials is essential.
5+ years of clinical research experience, in particular in clinical pharmacology. You are familiar with ICH-GCP regulatory guidance documents.
Good working understanding of pharmacokinetic questions, and a good familiarity of bioanalytical methods.
Experience working in a matrix environment and interacting with a variety of experts (e.g. CRO’s, vendors, consultants, clinical investigators, biostatisticians, clinical pharmacologists).
Advanced understanding and learning appetite of clinical practice in oncology and how clinical practice is evolving with the introduction of new therapies, in particular immunotherapy.
Proficiency in PK/PD and PBPK software, such as Phoenix Win-nonlin and PK-sim is a plus.



Skills and Capabilities
We are looking for a driven, structured, autonomous, self-motivated individual, who easily collaborates and communicates with others both orally and in writing. You have excellent business judgment, problem solving skills and you enjoy creating and participating in an efficient working environment. You have superior communication skills in cross-cultural environments, and you are proficient in written and spoken English. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.


The position is based in Lund, but there is flexibility with respect to presence in the office.


Application
If you match this profile and you are looking to contribute to the development of transformational cancer treatments, you are welcome to apply for the position.
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2021-03-19


BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben

Senior Clinical Scientist – Clinical Pharmacology
to join BioInvent’s clinical development team
At BioInvent, we are world experts on antibodies and cancer biology, and we strive for developing first or best-in-class immuno-modulatory antibodies to treat cancer; new drugs that have the potential to transform cancer treatment and the quality of life of cancer patients. At BioInvent we carry out all aspects of drug development, including preclinical research, manufacturing and clinical development.
Together we are creating an exciting future for patients, for our company employees and for our investors. We welcome you to be part of it - as a Senior Clinical Scientist.


Key Responsibilities
As a Senior Clinical Scientist, you will be part of our engaging clinical development team. You will support the development of critical and essential documents such as clinical study protocols, investigator's brochure, briefing packages, lab manuals, preclinical/clinical PK reports, and clinical study reports. You will be a point of contact for regulatory, PK/ADA, and other internal and external contributors. You will support regulatory submissions (e.g. INDs, CTAs) to European, US and other regulatory agencies. You will interact with pharmacodynamic (PD) scientists to support the development of BioInvent’s clinical drug candidates, as well as biomarker development. You will conduct literature reviews and prepare summaries to support clinical development decisions, and you will support the development of product concepts, target product profiles (TPPs), and clinical development plans for BioInvent’s drug candidates.
Requirements
MD or PhD degree or equivalent.
You have experience as a Clinical Scientist, and preferably experience of phase I/II studies in oncology and/or hematology. Knowledge about ICH-GCP and other relevant regulations to conduct clinical trials is essential.
5+ years of clinical research experience, in particular in clinical pharmacology. You are familiar with ICH-GCP regulatory guidance documents.
Good working understanding of pharmacokinetic questions, and a good familiarity of bioanalytical methods.
Experience working in a matrix environment and interacting with a variety of experts (e.g. CRO’s, vendors, consultants, clinical investigators, biostatisticians, clinical pharmacologists).
Advanced understanding and learning appetite of clinical practice in oncology and how clinical practice is evolving with the introduction of new therapies, in particular immunotherapy.
Proficiency in PK/PD and PBPK software, such as Phoenix Win-nonlin and PK-sim is a plus.



Skills and Capabilities
We are looking for a driven, structured, autonomous, self-motivated individual, who easily collaborates and communicates with others both orally and in writing. You have excellent business judgment, problem solving skills and you enjoy creating and participating in an efficient working environment. You have superior communication skills in cross-cultural environments, and you are proficient in written and spoken English. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.


The position is based in Lund, but there is flexibility with respect to presence in the office.


Application
If you match this profile and you are looking to contribute to the development of transformational cancer treatments, you are welcome to apply for the position.
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2021-01-11.


BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben

At BioInvent we are experts on antibodies and cancer immunology. We strive to develop first-in-class immuno-modulatory antibody-based - treatments that have significant potential to improve cancer outcome and cancer patients’ quality of life. We are based in Lund in Sweden and amongst our 70+ employees cover all parts for drug development including preclinical research, manufacturing and clinical trials. Together we are creating an exciting future of BioInvent and we welcome you to be part of this journey as one of our Specialist/ Senior Scientist Cell Line Development


We are seeking a Specialist/ Senior Scientist with hands-on experience in establishing high producing mammalian cell lines for cGMP manufacture of monoclonal antibodies. This position sits in Process Development group which is placed in the Division of Technical Operations responsible for all CMC related activities including process development, manufacturing, QC and QA. We generate cell lines, develop processes and supply BioInvent’s clinical projects with antibodies, and additionally serve external customers as a CMO. At BioInvent we mainly use CHO cells for production and cultivate cells in single use bioreactors in sizes up to 1000L.
Key Responsibilities
Design and execute cell line development activities
Generate regulatory compliant clonal stable cell lines with desirable quality attributes
Support upstream process development through design and execution of cell culture experiments
Share your expertise and be able to train and develop other team members
Interaction with customer
Draft and revise documents such as SOPs, methods and technical reports
Support preparing regulatory submissions
Identify, recommend and implement improvements related to routine functions
Strategic technology development
Be subject matter expert during audit

Requirements
Experience and Qualifications
Minimum 3 years experience of cell line development for cGMP manufacture of biologics
Expertise in cell line development, including vector construction, stable transfection, Pool and clone generation, clone evaluation and selection, cell age stability studies and research cell bank establishment
Experience in routine maintenance and analysis of suspension CHO cells
Documented ability to work across multiple projects in parallel
Experience in customer relations and project planning
Fluent in written and spoken English and understand Swedish

In addition, experience from vector engineering will be an advantage as we currently are working with novel technologies to optimize our vectors and expand our expression platform.
Skills and Capabilities
We are looking for a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent problem-solving skills and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Your attitude and personality are of great importance - you are thorough yet efficient and strongly committed to making things happen. You understand the importance of achieving results, being flexible and adjusting to our processes, keeping deadlines and securing the highest quality of your work. You are enthusiastic and enjoy generating results and achieving goals both individually and jointly with your team.
If you match above described profile and are excited to contribute to BioInvent’s important cancer research journey, we welcome you to apply for this position.
Other information
The position is a full-time position based in Lund, Sweden. The working hours are mainly day-time, but the service will to some extent also be associated with certain on-call work during weekends or evenings. You will report to Team Leader Process development & Manufacturing Support.


Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2020-01-04


BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben

Vi är experter på antikroppar och cancerbiologi och vi arbetar för att utveckla immunonkologiska läkemedel som påtagligt förbättrar behandlingen av cancersjukdomar och förlänger cancerpatienters liv. Vi arbetar med både forskning, produktion och kliniska försök. Vill du vara med och bidra till att skapa resultat inom forskningen mot cancer och vara en del i vår spännande framtid så är du välkommen att bli en del av vårt positiva och engagerade team.
Tillsammans är vi alla med och bidrar till vår spännande framtid och nu välkomnar vi dig att bli en del av vårt team som vår nya Kontrollingenjör.


Huvudsakliga arbetsuppgifter
Dina huvudsakliga arbetsuppgifter är arbete med miljökontroll, inklusive förekommande analyser, och att godkänna startmaterial. Kalibrering och underhåll av enklare instrument ingår också. Du kommer att utarbeta planer, trenda resultat och skriva rapporter. QC laboratoriet arbetar enligt GMP (Good Manufacturing Practice) så noggrannhet är en viktig egenskap hos dig som ska jobba med oss. Du kommer att arbeta i en dynamisk grupp med goda möjligheter till både karriär- och personlig utveckling. Vi arbetar i nära samarbete med våra kunder och direkt kundkontakt ingår i arbetet.
Profil
Du är högskoleutbildad, lämplig bakgrund är Läkemedelstekniker, Biomedicinsk analytiker eller annan relevant utbildning. Erfarenhet GMP-(kvalitetsstyrd) verksamhet är meriterande. Erfarenhet av mikrobiologiska metoder och aseptisk hantering är önskvärt. Du trivs i en miljö där du får arbeta kvalitetsmedvetet, då det i ditt ansvar ligger även att säkerställa att dina uppdrag och uppgifter utförs och dokumenteras enligt GMP.
Viktiga personliga egenskaper är ansvarskänsla, noggrannhet, flexibilitet och samarbetsförmåga. Du förstår vikten av att uppnå resultat, hålla deadlines och säkerställa hög kvalitet inom ditt arbete. Du är entusiastisk, har en vilja att lära dig nya saker och tycker om att skapa resultat och uppnå mål både individuellt och tillsammans med teamet.
BioInvent arbetar på en utpräglat internationell marknad vilket innebär att du, förutom svenska, måste behärska engelska i tal och skrift.
Övrigt
Tjänsten är en heltidstjänst baserad i Lund. Arbetstiden är främst dagtid, men anpassas efter processerna vilket kräver flexibilitet. Kvälls- och helgarbete kan förekomma.
Ansökan
Vill du vara med och bidra till cancerforskningen som en del av BioInvent och vår spännande framtid och du dessutom passar in på beskrivningen ovan så tveka inte att skicka in din ansökan till oss!
Välkommen med din ansökan (CV och personligt brev) via https://careers.bioinvent.com/ senast den 25 oktober 2020. Vi arbetar med löpande urval och intervjuer vilket innebär att tjänsten kan komma att tillsättas tidigare än sista ansökningsdatum så skicka gärna din ansökan så snart som möjligt.


BioInvent är medlemmar i Innovations- och kemiarbetsgivarna och följer tjänstemannaavtalet, våra fackliga kontaktpersoner är Fredrik Wiberg, Akademikerföreningen och Jenny Nilsson, Unionenklubben.


Vi undanber oss vänligt men bestämt direktkontakt med bemannings- och rekryteringsbolag samt säljare av ytterligare jobbannonser.

At BioInvent, we are experts on antibodies and cancer biology and strive for developing first-in-class immuno-modulatory antibodies to treat cancer; treatments that have the potential to considerably improve cancer therapy and the life quality of cancer patients. In our biotech company we are approximately 60 employees and we are covering all parts for drug development, including preclinical research, manufacturing and clinical trials.
Together we all create the exciting future of BioInvent and we welcome you to be part of it - as one of our Clinical Project Managers.

Key Responsibilities
As a Clinical Project Manager you will be part of our positive and engaging clinical development team. You will be leading the team through all aspects of study planning from BID defense meeting to study report. You will communicate and interact with contract research organizations (CROs) and other vendors to ensure smooth study set up and study conduct. You have the oversight of study budget, study timelines, CRO/vendors and site performance and maintaining awareness and solutions of issues raised. You will also support all other involved functions for example the medical expert, regulatory expert and the medical writer.
When needed, you participate in site evaluation visits, site initiation visits and other meetings. Documentation, information and communication both internally and externally is a great part of your responsibility and you also have to reassure that assignments and tasks are performed in line with ICH-GCP and relevant regulation for the conduct of clinical trials.
Requirements
You have experience as a Clinical Project Manager and/or Clinical Trial Manager, preferably experience of phase I/II studies in oncology and /or hematology. Knowledge about ICH-GCP and other relevant regulation to conduct clinical trials is a requirement. Knowledge of IND submission to FDA and other competent authorities and experience of contract and budget negotiations with CROs, vendors, consultants and sites is preferable. You have good computer skills and are knowledgeable in the use of Microsoft Project or similar platform for internal trail setup and oversight. You are proficient in written and spoken English.
The position is office based in Lund.
Skills and Capabilities
We are looking for a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent business judgment, problem solving and negotiation skills and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Personal suitability is of great importance and we believe that you are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines and to secure high quality within your work. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.
To summarize, BioInvent has several value driving factors in place with great potential for the future. If you match the described profile and would like to contribute to important cancer research as a part of BioInvent and our exciting future, you are welcome to apply for the position!


Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2020-08-10.


BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben