Scientific Materials Leadership Opportunity
12 hours ago
As a Team Lead/Manager, Material Science, you will oversee and support your team in introducing new raw materials and maintaining GMP documentation. You will ensure regulatory compliance, assess vendor change notifications, and provide strategic input on raw material-related matters.
Key Responsibilities- Facilitate and evaluate the introduction of new raw materials and single-use systems 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.
To be successful in this role, you will need:
- 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.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. We are an equal opportunity employer and welcome applications from diverse candidates.
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