Process Validation Specialist/Coordinator

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København

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com.

PROCESS VALIDATION SPECIALIST/COORDINATOR

A challenging and varied job in our Process Transfer Department in Copenhagen as a process validation specialist/coordinator is open for a quality-minded new colleague with biopharmaceutical 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 facility for clinical and commercial supply. With AGC Biologics increasing activities, we are looking for new colleagues with process validation experience in manufacturing of biopharmaceuticals.

The Process Validation Specialist/Coordinator is responsible for designing validation plans, providing strategic direction, compiling data and completing validation reports at AGC for commercial manufacturing.

Key responsibilities:

  • Provide strategic leadership to carry out validation projects

  • Designing validation plans and preparing validation reports

  • Comply with all company policies, procedures, internal and external quality standards, and relevant regulatory standards

  • Support to GMP upstream and downstream manufacturing processes


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

The Department

In our Process Transfer department, we are currently 15 highly skilled scientists, 2 student assistants, 1 manager and 1 Director. You will be a part of the process validation team headed by the process validation manager, as part of the Process Transfer department headed by the director. We have an open communication and strong support and flexibility within the department.

The department 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 department is responsible for, and coordinates, process risk assessment and process validation activities. The department is recognized as a group of process subject matter experts and very often provides input in meetings with potential new customers and audits. The department are furthermore involved with inspections with both national and global authorities.

Your profile

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

  • Degree in science, engineering, or a related field (MSc. or PhD)

  • Experience with process validation in biopharmaceutical production

    • 5+ year experience in a regulated (cGMP) manufacturing environment

    • 2+ year experience as a process validation specialist


  • Fluency in English, written and verbal

  • Ability to effectively communicate with others engaging with costumers and colleges of various cultural background, with an ability to obtain buy-in from all key stakeholders

  • Familiar with EMA, FDA, and ICH regulations

  • Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks


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, in accordance with our slogan - Right. On Time.

For further information please contact Henrik Næsted, Director of Process Transfer, [email protected]

We will process the applications in the order they arrive. Therefore, please submit your application and CV as soon as possible and no later than November 15. 2019.


Information og data

Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 23.10.2019, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Produktspecialist
  • København
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