Senior Materials Manager
3 days ago
About AGC Biologics:
We are a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow.
Job Description:
The Senior Materials Manager will oversee and support the introduction of new raw materials and the meticulous maintenance of GMP documentation. This role is responsible for ensuring regulatory compliance, assessing vendor change notifications, and providing strategic input on raw material-related matters. As the leader of our Material Science Team, you will oversee 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.
About the Department:
The Process Transfer Department operates within the MSAT function at AGC Biologics and consists of three specialized teams: Upstream Process Transfer, Downstream Process Transfer, and Material Science. We are currently seeking to augment the Material Science team with a Senior Materials Manager. Our workplace fosters a collaborative atmosphere characterized by open communication, mutual support, and a flexible approach across all teams.
Your Responsibilities Will Include:
- Facilitate and evaluate the introduction of new raw materials and single-use systems (SUS) into AGC Biologics.
- Generate and oversee Change Requests for the introduction, modification, and discontinuation of raw materials/SUS.
- 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 Have:
- 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.
- Prior experience in managing raw materials, disposables, or consumables within a GMP manufacturing environment is considered a plus.
- Self-motivated, organized, and proactive approach to work.
- Good understanding of scientific principles relevant to biopharmaceutical manufacturing, including an understanding of material attributes and their impact on process chemistry and product quality.
- 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.
- Experience in mentoring and developing high-performing teams.
- 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.
- Good problem-solving and critical-thinking abilities to address material-related challenges and implement solutions.
- Ability to manage multiple tasks simultaneously, prioritize tasks effectively, and meet deadlines in a fast-paced environment.
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