Manager, Quality Control

1 week ago

København, Denmark AGC Biologics Full time

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Experienced People Manager for QC Chemistry HPLC Scientists, Quality Control

Can you lead and develop a growing team of dedicated, empowered QC HPLC Scientists?

As Manager of QC Chemistry HPLC Scientists you will be the head of a growing unit responsible for (U)HPLC, iCIEF and CGE-SDS method validations, QC Coordination, analytical data generation (batch release, stability data, in-process Stop/Go samples), ILI and OOS investigations, troubleshooting, Customer interactions, Audit and Inspection participation and Health Authority Q&As.

About the Role

You will head up a unit of 10 skilled Scientists working in close collaboration with a sister unit of 12 highly skilled and independently functioning Analytical QC Technicians and a Lab Support Scientist, headed by a Manager colleague.

We are offering a job with considerable individual responsibility and challenges, and the opportunity to use and develop your leadership skills. As Manager of QC Chemistry Scientists, your main focus is to empower team members to secure Customer deliverables, lead and develop your growing unit in accordance with our Company Core Values of Teamwork, Quality, Trust, Knowledge, Ingenuity and Accountability and to live up to GMP regulations. You are expected to develop your employees, build capabilities, secure transparency, optimize resource prioritisation and collaborate proactively in the leader group and in cross-organisational assignments.

About the QC Chemistry Department

QC Chemistry is one of five departments in the QC area. QC Chemistry is responsible for supporting the production of new biopharmaceuticals by performing analytical testing and validating various analytical procedures according to ICH guidelines from clinical phase I to phase III and commercial. QC Chemistry has close collaboration with departments across the QC area and with internal stakeholders in AGC Biologics.

You will join a small and well-functioning leader team with a Manager colleague and a Director, and you will report directly to the Director of QC Chemistry.

QC Chemistry is a passionate and dedicated department and we strive to support our internal stakeholders, our Customers and the patients they are serving. We are here to help, provide guidance and secure that challenges are resolved and scientific questions are answered. We are driven by a high level of integrity, science, passion for our work and an open minded, collaborative approach, putting the task before the ego.

Candidate Profile
  • You have a university degree within natural sciences (Master Degree or Ph.D in e.g. Pharmacy, Biochemistry, Engineering or equivalent)
  • You have 3+ years of managerial experience from leadership positions
  • You have 5+ years of experience from the pharmaceutical industry in CMC related areas, e.g. CMC development, manufacturing or analytical departments
  • A solid understanding of GMP regulations, documentation and traceability, analytical methods for marketed products, stability study establishment and reporting, statistics, OOS resolutions, technical transfer of analytical methods and experience from interactions with regulatory authorities including inspections
  • 2+ years experience with LEAN in a service area
  • A proactive and open-minded approach
  • Since the job involves multiple tasks with fixed deadlines ongoing at the same time, the ability to focus, stay calm and work independently as well as in teams, is a necessity
  • Strong collaboration skills and experience from working in cross functional teams
  • Strong proficiency in written and spoken English
Are You Up for a Challenge?
  • To apply, please submit your CV. We encourage you to apply, even if you don't meet every requirement.
  • If we see a potential match, one of our recruiters will contact you to discuss your application.
  • If both sides remain positive after this discussion, we will move forward to the assessment stage to evaluate the key skills required for the job.
  • Applications are reviewed on a rolling basis. You do not need to attach a cover letter, but please include a few sentences about your motivation for applying to this position.

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

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