Senior Material Scientist Team Lead

7 hours ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

We are seeking a Senior Material Scientist Team Lead to join our Process Transfer Department in Copenhagen. This role offers an exciting opportunity to lead and support the growth of our Material Science Team, while ensuring regulatory compliance and providing strategic input on raw material-related matters.

About the Job

The Senior Material Scientist Team Lead will oversee and support their team with the introduction of new raw materials and the meticulous maintenance of GMP documentation. Key responsibilities include ensuring regulatory compliance, assessing vendor change notifications, and providing strategic input on raw material-related matters.

As a leader, you will be responsible for supporting the growth of your team and defining roles and responsibilities together with stakeholders. The team consists of 3 Material Scientists and 5 Student Assistants who currently support the drafting of material specifications for all single-use systems 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 Material Scientist Team Lead. Our workplace fosters a collaborative atmosphere characterized by open communication, mutual support, and a flexible approach across all teams.

Your Role
  • 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 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.
Salary Range

The estimated salary range for this position is €60,000 - €80,000 per annum, depending on qualifications and experience.

Benefits

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. As an equal opportunity employer, we welcome applicants from diverse backgrounds and cultures.

Location

Copenhagen Site

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