Senior Cmc Manager, Msat (biologics)

Hansa Biopharma

Lund, Sweden
**
Gmp manufacturing of biologics
Cdmo/cmo oversight experience
Regulatory authority interactions
** Hansa Biopharma is seeking a Senior CMC Manager for MSAT (Biologics) in Lund, Sweden, to lead CMC processes and ensure operational excellence in biologics manufacturing and GMP compliance. The ideal candidate should have extensive experience in biologics manufacturing, quality systems, and regulatory interactions. **

Job Summary

  • The role involves leading CMC processes to ensure operational excellence and regulatory compliance for externally manufactured drug substance and product batches.
  • Candidates will act as the internal Subject Matter Expert for biologics quality, managing deviations, change controls, and CAPAs while supporting interactions with global health authorities.
  • Hansa Biopharma offers a dynamic, science-driven environment where employees contribute to life-changing outcomes for patients with acute immune disorders.

Matching Summary

Match Score: 75

** Hansa Biopharma is seeking a Senior CMC Manager for MSAT (Biologics) in Lund, Sweden, to lead CMC processes and ensure operational excellence in biologics manufacturing and GMP compliance. The ideal candidate should have extensive experience in biologics manufacturing, quality systems, and regulatory interactions. **

Skills & Requirements

Must-have

  • GMP manufacturing of biologics
  • CDMO/CMO oversight experience
  • Regulatory authority interactions
  • Deviation investigation management
  • Master Batch Record approval

Nice-to-have

  • Strategic thinking in quality systems
  • Science-based compliance culture
  • Collaborative team environment
  • Risk-based decision making

Key Requirements

  • M.Sc. in Pharmaceutical Sciences or related field
  • 8+ years GMP biologics manufacturing experience
  • Experience with clinical and commercial manufacturing
  • Proven track record overseeing CDMOs/CMOs
  • Strong English communication skills

Work Rights

Not specified

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