Manager, QC Chemistry

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.

Manager for QC Chemistry HPLC Scientists, Quality Control

Are you passionate about leading people? Can you lead and develop a growing team of dedicated, empowered Validation Scientists and Subject Matter Experts?

As (Senior) Manager of QC Chemistry HPLC Validation Scientists you will be the head of a growing unit responsible for (U)HPLC, iCIEF and CGE-SDS method validations, 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.

The team

You will head up a unit of 10 skilled Scientists working in close collaboration with a sister unit of 13 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 (Senior) 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 prioritization and collaborate proactively in the leader group and in cross-organizational assignments.

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, as well as interacting with Customers and Authorities on method related topics. 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.

Your Profile

You have a clear head and a positive attitude and know how to balance your strong business mindset with a profound understanding of human nature. You use your personal impact and pro-active can-do attitude to make the team win and your largest success is to see your organisation thrive and function. You are an excellent collaborator and communicator and have the ability to motivate others. You have a strong preference for being logical, honest and solution oriented and have a good sense of humour and ability to make things work out.

• 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

Your Application
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