Biopharmaceutical Material Scientist Lead

3 days ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

About the Role:

The Biopharmaceutical Material Scientist Lead will be responsible for facilitating and evaluating the introduction of new raw materials and single-use systems (SUS) into AGC Biologics. This role requires generating and overseeing Change Requests for the introduction, modification, and discontinuation of raw materials/SUS. You will develop and maintain Material Specifications and related Standard Procedures, acting as a scientific liaison between the Materials/Procurement and Process teams.

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:

  • 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.
  • Develop and maintain relationships with key stakeholders, including suppliers, vendors, and internal teams.
  • Provide technical expertise and guidance to ensure compliance with GMP regulations and industry standards.
  • Analytical and problem-solving skills to identify root causes of material-related issues and implement corrective actions.

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.
  • Strong analytical and problem-solving skills to identify root causes of material-related issues and implement corrective actions.
  • 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 and interpersonal skills to build strong relationships with internal teams and external stakeholders.
  • Leadership and management skills to mentor and develop high-performing teams.
  • Ability to work in a fast-paced environment with multiple priorities and deadlines.

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