Biologics QC Team Lead
7 days ago
To be successful in this role, you will need to have a deep understanding of Quality Control processes and procedures, as well as excellent communication and collaboration skills. You will also need to be able to work effectively in a fast-paced environment with changing priorities.
About the Role
This is an exciting opportunity to join a dynamic team and contribute to the development of new treatments for brain diseases. As a Senior Quality Control Scientist, you will play a key role in ensuring the quality of our development biological drugs and collaborating with cross-functional teams to achieve our goals.
Your Key Responsibilities
- Technical lead and subject matter expert for Quality Control activities with focus on drug-device combination products
- Working closely with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities, e.g., sampling plans, Certificate of Analysis, stability studies, method validation etc.
- Reviewing and approving protocols, reports, and other documents for studies performed internally and at contract laboratories
- Collaborating within project teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs
- Supporting regulatory filings and other interactions with Health Authorities
What You Will Bring
You are a highly skilled Senior Quality Control Scientist with minimum 5 years of experience in the biotech or pharmaceutical industry. You have an accredited bachelor's degree (or higher) in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equal. In addition, you bring:
- 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 (e.g., SE-H/UPLC, CE-SDS, icIEF, soloVPE, potency ELISA)
- Advanced English verbal and written communication skills
Our Culture
Lundbeck is a global pharmaceutical company that values diversity, inclusion, and collaboration. We believe that every employee brings unique perspectives and experiences that help us achieve our goals. We strive to create a workplace culture that is inclusive, supportive, and empowering.
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