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AGC Biologics A/S

Indrykket 07-09-2020

Supervisor for the Batch Review Center

Are you passionate about providing innovative solutions to complex challenges? Do you have people manager experience or skills, and experience with API production or other areas within the pharmaceutical industry? Then come join our newly established Batch Review Center as supervisor.

With AGC Biologics expanding activities we are looking for new supervisors to lead our newly established Batch Review Center.

AGC Biologics delivers biopharmaceutical development and manufacturing of Drug Bulk Intermediates/Active Pharmaceutical Ingredients for both clinical studies as well as for the global market.

AGC Biologics is an international and modern organization with production sites in Europe, Japan and US. AGC Biologics is the largest contract development and manufacturing organization (CDMO) in the world and currently AGC Biologics employees more than 900 people worldwide where app. 460 are situated in Denmark close to Copenhagen.

The Batch Review Center team
The Review Center is responsible for review of batch documentation and handling of compliance deviations and CAPAs associated with the batches. The center is part of our manufacturing department, which produces therapeutic proteins for pre-clinical, clinical and commercial use for a wide range of different customers from around the world.

The position
As supervisor for the Review Center, you will be the direct leader for a team consisting of approx. 9 highly dedicated scientists and technicians working closely together with internal stakeholders like QA, QC, consultants and project management. 

You will be responsible for:
• Planning and coordination of the daily tasks in the Batch Review Center.
• People management, hiring and developing people, conducting mid-and end year appraisals.
• Board meetings, KPI delivery and follow-up.
• In collaboration with the team, ensure that batch records from the manufacturing campaigns are reviewed internally and meet quality standards.
• Ensure that manufacturing compliance deviations, root cause investigations and CAPAs are managed and completed in an efficient and timely manner.
• Optimization and standardizing the flow related to the batch release process.

The team works intensively with cGMP, quality systems and LEAN, and you will have great opportunity to develop the Batch Review Center and at the same time develop your own leadership skills.

The ideal candidate  have previously been leading manufacturing teams, operating under cGMP preferably within the pharmaceutical industry. The ideal candidate for the position has several of the below competencies/experiences:
• A scientific education (B.Sc. or M.Sc) 
• Several years of experience working in a cGMP environment within the pharmaceutical industry
• A few years of leadership experience preferably in a manufacturing setting
• As it is expected that the supervisor will also take part in daily tasks, it is a plus to have experience handling review of batch documentation, deviation reports and CAPAs.
• Excellent collaboration skills.
• Strong English communication skills, both written and verbal
• Structured and analytical oriented
• Experience with applied LEAN and a genuine interest in standardizing and optimizing flows

As a person, you have a positive mindset; have flexibility and a desire to take on new tasks and responsibilities. You strive in a dynamic environment where sudden changes may occur, so it is important that you can cope with such uncertainties.

AGC offers
AGC Biologics offers a dynamic working place with good opportunities for working with a varied array of tasks and challenges. This opens many doors for personal development and for you to make a real difference towards both patients and customer. At AGC Biologics the work environment is informal and humor is part of the work day. We respect each other and our differences, and we help each other to reach deadlines together as one team.

For further information please contact Manager Sanne Bové Dehn, phone +45 22 94 29 30.

We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidates are found the ad will close.

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AGC Biologics A/S
Vandtårnsvej 83B
2860 Søborg
2860 Søborg
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AGC Biologics A/S
Gladsaxe, Storkøbenhavn
AGC Biologics A/S
Gladsaxe, Storkøbenhavn
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