Material Management Scientist, Process Transfer & Validation

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.

Are you a quality-driven professional with experience in introducing and maintaining GMP raw materials for biopharmaceutical processing? AGC Biologics in Copenhagen is seeking a talented individual to join our Process Transfer & Validation (PT&V) Department as a Material Management Scientist.

About the Team & Department

The Process Transfer & Validation (PT&V) Department consists ofthree specialized teams: Upstream Process Transfer, Downstream Process Transfer, and Material Science. We are currently seeking to augment the Material Science team with a new colleague. You will be joining two existing team members and a Team Leader, working alongside the rest of the department, which totals 40 employees and 4 Student Assistants. Our workplace fosters a collaborative atmosphere characterized by open communication, mutual support, and a flexible approach across all teams.

About the Role

As a key member of the Material Science, Process Transfer & Validation Team, you will play an important role in introducing new raw materials and maintaining GMP documentation. Your responsibilities will include ensuring compliance with regulatory requirements, assessing vendor change notifications, reviewing, drafting, and updating raw material documentation and providing crucial input on raw material-related issues in a GMP environment.

As a valued team member, 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.

• Strong experience working in the biopharmaceutical industry, preferably in material management or a related function.

• 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.

• Excellent 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.

• Strong communication skills, both verbal and written, with the ability to effectively collaborate with cross-functional teams including procurement, quality assurance, and manufacturing.

• 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?

• To apply, please submit your CV. We encourage you to apply even if you do not meet every requirement.

• If we see a potential match, one of our recruiters will contact you to discuss your application.

• 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.

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. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

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