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Material Science Team Lead
1 month ago
About the Job
We are seeking a highly skilled and experienced Material Science Team Lead to join our team at AGC Biologics in Copenhagen. As a key member of our Process Transfer Department, you will be responsible for overseeing the introduction of new raw materials and single-use systems (SUS) into our manufacturing process.
Key Responsibilities
- Facilitate and evaluate the introduction of new raw materials and 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.
Requirements
- 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.
About AGC Biologics
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 https://www.agcbio.com/
Our Culture
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.
Equal Opportunity Employer
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.
