Senior Scientist, Supplier Quality Management

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.

Our Quality Systems (QS) department is looking for a Senior Scientist, who is experienced in Supplier Quality Management (SQM) to join the SQM team.

Role and Responsibilities
Our SQM team is supporting a site manufacturing clinical and commercial drug substances, and you will be part of a smaller team responsible for supplier qualifications, assessments and evaluations, supplier audits, and supporting the site as a subject matter expert during audits and inspections.

The critical responsibilities of the Senior Scientist will be utilizing previous experience with all aspects of Supplier management - previous experience as a trained lead auditor is an advantage. The role requires attention to detail, and comfort interacting cross-functionally with internal and external partners.

The QS department
The SQM team is part of the QS department and is an important part of the Quality organization. You will be joining a diverse team of highly qualified colleagues, all with several years of experience within quality assurance, and you will report to the Manager for the SQM team. We are actively involved in the constant development and improvement of the quality system and our facility in Søborg and have a close collaboration with our global AGC sites.

The team works closely together with the Quality Operations team, and Supply Chain Management and routinely collaborates with partners across all functional areas at the site, to ensure all quality-related activities are carried out effectively, efficiently, and in compliance with cGMP. We keep an open communication with focus on a high level of professionalism and we are committed to providing high-quality service to our colleagues in the rest of AGC, to our customers, and to our suppliers as well.

Candidate Profile

• Preferably +5 years working experience in a Biotech/Pharmaceutical production environment, preferably with focus on supplier quality.
• Education in pharmacy, biochemistry, or related life sciences field - a Master’s degree or PhD is an advantage, but not a requirement.
• Strong knowledge of GMP guidelines, as well as international regulations, pertaining to the production of biopharmaceutical products (including, but not limited to 21 CFR Parts 11, 210, 211, 600, and 610; EU GMP Parts I, II, and III, and relevant ICH guidelines).
• Experienced lead auditor (e.g.: ISO 9001, GMP)
• Proven technical writing skills.
• Skills in verbal communications. Ability to respond to complex inquiries from customers, co-workers, and suppliers.
• Skilled in time and priority management.
• Demonstrated ability to work collaboratively to accomplish deadlines and objectives.

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