Denmark Job Openings

AGC Biologics
GMP Material Scientist
Copenhagen
FULL TIME
September 24, 2024
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Facilitate and evaluate the introduction of new raw materials and single use systems (SUS) into AGC Biologics.
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Generate and oversee Change Requests for the introduction, modification, and discontinuation of raw materials/SUS.
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Develop and maintain Material Specifications and related Standard Procedures.
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Act as a scientific liaison between the Materials/Procurement and Process teams.
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Collaborate with Supplier Qualification Management, Procurement, QA, and Process Teams to assess material and supplier risks.
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Lead or coordinate investigations and changes related to materials used in manufacturing.
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Partner with manufacturing Process Team counterparts to investigate materials issues and implement necessary changes.
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Hold a Bachelor's, Master's, or Ph D degree in a relevant scientific field such as Chemistry, Biochemistry, Biology, Chemical Engineering, or a related discipline.
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Experience working in the biopharmaceutical industry, preferably in material management or a related function.
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Self-motivated, organized, and proactive approach to work.
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Good understanding of scientific principles relevant to biopharmaceutical manufacturing, including an understanding of material attributes and their impact on process chemistry and product quality.
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Familiarity with Good Manufacturing Practices (GMP) and regulatory requirements pertaining to material management in biopharma.
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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.
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Strong communication skills, both verbal and written, with the ability to effectively collaborate with cross-functional teams including procurement, quality assurance, and manufacturing.
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Good problem-solving and critical-thinking abilities to address material-related challenges and implement solutions.
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Ability to manage multiple tasks simultaneously, prioritize tasks effectively, and meet deadlines in a fast-paced environment.
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To apply, please submit your CV. We encourage you to apply, even if you don't meet every requirement.
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If we see a potential match, one of our recruiters will contact you to discuss your application.
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If both sides remain positive after this discussion, we will move forward to the assessment stage to evaluate the key skills required for the job.
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 (p DNA), messenger RNA (m RNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with c GMP-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. Want to keep posted about our growth and learn more about our company? Follow us on
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