Senior Raw Materials Manager

1 month ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
Job Overview:
A Senior Raw Materials Manager is sought to lead our Material Science Team within the MSAT department at AGC Biologics in Copenhagen. This role will be responsible for overseeing and supporting the introduction of new raw materials, maintaining GMP documentation, ensuring regulatory compliance, and providing strategic input on raw material-related matters.

About the Role:
This newly established position offers an exciting opportunity to support the growth of a relatively new team and define roles and responsibilities with stakeholders. The successful candidate will oversee 3 Material Scientists and 5 Student Assistants who currently support the drafting of material specifications for single-use systems used at AGC Biologics Copenhagen.

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.

Requirements:
To be successful in this role, you will require:
  • 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.

Benefits:
As a valued member of our team, you can expect a highly competitive compensation package, a friendly, collaborative culture that values personal initiative and professional achievement, and opportunities for rapid personal and professional growth.

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