GMP Raw Materials Specialist
3 days ago
About the Job:
The GMP Raw Materials Specialist will be responsible for ensuring regulatory compliance, assessing vendor change notifications, and providing strategic input on raw material-related matters. This role requires collaborating with Supplier Qualification Management, Procurement, QA, and Process Teams to assess material and supplier risks. You will lead or coordinate investigations and changes related to materials used in manufacturing, partnering with manufacturing Process Team counterparts to investigate materials issues and implement necessary changes.
About the Team:
The Material Science Team operates within the MSAT function at AGC Biologics and consists of 3 Material Scientists and 5 Student Assistants who currently support the drafting of material specifications for all the single-use systems (SUS) used at AGC Biologics Copenhagen. Our workplace fosters a collaborative atmosphere characterized by open communication, mutual support, and a flexible approach across all teams.
Your Key Responsibilities:
- Develop and maintain Material Specifications and related Standard Procedures.
- Act as a scientific liaison between the Materials/Procurement and Process teams.
- Collaborate with Supplier Qualification Management, Procurement, QA, and Process Teams to assess material and supplier risks.
- Lead or coordinate investigations and changes related to materials used in manufacturing.
- Partner with manufacturing Process Team counterparts to investigate materials issues and implement necessary changes.
You Possess:
- A Bachelor's, Master's, or PhD degree in a relevant scientific field such as Chemistry, Biochemistry, Biology, Chemical Engineering, or a related discipline.
- Management/leadership experience in clinical and/or commercial GMP manufacturing.
- Familiarity with Good Manufacturing Practices (GMP) and regulatory requirements pertaining to material management in biopharma.
- Understanding of regulatory guidelines and standards relevant to material management in the biopharmaceutical industry, such as ICH Q7A, 21 CFR Part 211, and relevant ISO standards.
- Excellent communication skills, both verbal and written, with the ability to effectively collaborate with cross-functional teams including procurement, quality assurance, and manufacturing.
- Proven ability to prioritize tasks and drive interdepartmental collaboration towards achieving common goals.
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