Team Lead/Manager, Material Science

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.

Team leader/Manager, Material Science Team
Are you an experienced professional with a keen eye for quality and extensive experience in managing GMP raw materials within the biopharmaceutical industry? AGC Biologics in Copenhagen is currently seeking a dynamic individual to lead our Material Science Team within the MSAT, Process Transfer Department.

About the job
As the leader of our Material Science Team, you will oversee and support your team with the introduction of new raw materials and the meticulous maintenance of GMP documentation. Your primary responsibilities will include ensuring regulatory compliance, assessing vendor change notifications, and providing strategic input on raw material-related matters. It is a newly established position and a relatively new team; therefore, an important part of your job will be to support the growth of your team and define together with our stakeholders the roles and responsibilities of your team. The team consists of 3 Material Scientists. In addition, you will be in charge of 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 Team leader/Manager. Our workplace fosters a collaborative atmosphere characterized by open communication, mutual support, and a flexible approach across all teams.

As a valued team member in MSAT, you will have the opportunity to assume significant responsibilities while receiving ample support from your colleagues to enhance and refine your skills. Expect rapid personal and professional growth, as we actively promote the individual development of our employees, fostering a collaborative environment where both personal and professional advancement are encouraged. While the role primarily entails office-based work, we provide flexibility to work remotely when feasible.

You will…

• 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.

Are you up for a challenge?

• Apply with your CV (In English please)
• If we see a match, you'll have a call with one of our recruiters to share more about what you can bring to the team.
• Are both sides still positive? Then we proceed to the assessment stage to assess key skills required for the job Confidential
• We will be conducting interviews on an ongoing basis and will close the position once the successful candidate has been found.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is 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. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.

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AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Location: Copenhagen Site