Senior Quality Control Specialist
1 month ago
We are seeking a highly skilled Senior Quality Control Scientist to join our international CMC Biologics Quality Control team. As a key member of our team, you will be responsible for ensuring the quality of our development biological drugs from Phase I to Phase III.
Key Responsibilities- Technical lead and subject matter expert for Quality Control activities with focus on drug-device combination products.
- Collaborate with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities.
- Review and approve protocols, reports, and other documents for studies performed internally and at contract laboratories.
- Collaborate within project teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs.
- Support regulatory filings and other interactions with Health Authorities.
Our CMC Biologics team is a global organization with over 100 employees, split between Lundbeck Headquarters in Copenhagen, Denmark and Lundbeck Process Development Center of Excellence in Seattle, WA, USA. As a Senior Quality Control Scientist, you will work out of our headquarters in Valby, Copenhagen, and report to the Senior Manager Quality Control.
Requirements- Minimum 5 years of experience in the biotech or pharmaceutical industry.
- Accredited bachelor's degree (or higher) in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equal.
- Experience in drug-device combination products.
- Good understanding of GDP/GMP guidelines.
- Knowledge of the United States Pharmacopoeia and the European Pharmacopoeia.
- Understanding of methods used to test biological molecules.
- Advanced English verbal and written communication skills.
Lundbeck is a global pharmaceutical company that is passionate about improving the lives of people affected by brain disorders. We offer a collaborative and dynamic work environment, with opportunities for career development and growth.
We are committed to building a diverse and inclusive workforce, and we welcome applications from candidates from all backgrounds.
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