Denmark Job Openings
AGC Biologics
Scientist, Senior/Principal Scientist, Quality Control
Copenhagen
FULL TIME
October 18, 2024
- Author and review raw material specification based on European or US regulatory guidelines as well as adapting to supplier change notifications
- Deliverance of scientifically sound and c GMP compliant raw material documents and analytical results.
- Involvement in operating the raw material program, including risk assessments and creating qualification protocol/reports
- Oversight of sampling, as well internal as outsourced testing.
- Profound writing and reviewing skills of c GMP documents: raw material specifications, test methods, general procedures
- Experience setting specifications for compendial and non-compendial raw materials
- In depth understanding of US and European pharmacopoeias
- Experience handling change controls, deviations and CAPAs including root cause investigation, and Laboratory Investigations
- You are an experienced multi-tasker and you enjoy working in a high pace and being challenged in a busy business
- You are a team player combined with the ability and desire to work independently
- Experience with contract manufacturing and business understanding
- Experience in representing area in Audits and Inspections
Submit your application as soon as possible. We treat the applications as we receive them, and conduct interviews with qualified candidates. When the right candidate is found, the add will close. For further information regarding the position, please contact Senior Manager, Stella Brudin, QC Raw Materials, at ssbrudin@agcbio.com
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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