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Downstream Process Scientist / Principal Scientist for Process Transfer

A challenging and varied job in our Process Transfer Department in Copenhagen is open for a quality-minded new colleague with extensive downstream processing experience and a strong ability to drive interdepartmental collaboration.

The Job

AGC Biologics continues to enjoy great success, with a steadily increasing number of projects – many of which are late stage development projects preparing for commercial launch. More specifically, we have several projects active in the process validation stages from initial process risk assessment to execution of PPQ runs. At the same time, we are still handling many new and exciting customer projects and give support to processes already running in our GMP facility for clinical and commercial supply. With AGC Biologics increasing activities, we are looking for new colleagues with extensive downstream processing experience and preferably with experience within process validation.

You will from a position as Scientist / Principal Scientist in Process Transfer take part in key activities for downstream development in both microbial and mammalian processes (including demanding perfusion processes). You will be responsible for:

  • Process transfers from globally site to site, customers, and development into our manufacturing area
  • Support of process validation activities of downstream bioproduction preparing for marketing authorization
  • Support to GMP downstream manufacturing processes

The position offer interaction with a large number of stakeholders, and is unique in having contact with both our global sites, customers and all internal departments involved in process development, manufacturing and validation of downstream processes. You will be introduced to biopharmaceutical companies from all over the world and be an active player in their projects.  The daily challenges will vary a lot, and two days will never be the same.

The final job description will depend on the profile of our new colleague.

The Department

The Process Transfer department currently consists of 15 highly skilled scientists, 2 assistants, 1 team lead (vacant), 1 manager and 1 head of department. The department is divided in sub teams corresponding to process validation governance and upstream/downstream process transfer.

The team is responsible for transfer of processes from customers to AGC Biologics and between development and manufacturing internally, as well as between AGC manufacturing sites globally (Denmark, United States, Germany, and Japan). Furthermore, the team is responsible for, and coordinates, process risk assessment and process validation activities. The team is recognized as a group of process subject matter experts and very often provides input in meetings with potential new customers and audits with authorities and costumers as SME’s.

Your profile

In our new colleague we’re looking for a person with:

  • Preferably a PhD or alternatively a master degree in science with several years’ experience with downstream processing of biopharmaceuticals
  • Strong knowledge of process development and process technology in general within downstream processing
  • cGMP experience and knowledge of regulatory requirements for late stage development
  • Excellent with English communication and collaborative people skills engaging with costumers and colleges of various cultural background, with an ability to obtain buy-in from all key stakeholders
  • A flexible approach and desire to take on and drive new tasks and responsibilities
  • Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks
  • Experience with process validation of biopharmaceutical(s) is a must

AGC Biologics Copenhagen

AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will to a large extent be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, complaint with our slogan - Right. On Time.

Applicants must comply with the stipulated requirements.

We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the add will close. We are therefore looking forward to receive your application today!

About AGC Biologics
AGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of AGC Biologics’ innovative approach to cell line and process development.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing. 


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