Senior Scientist - Cell Culture Lead

Roche

Shanghai, China
Cell line development strategy execution
Mammalian cell culture process scale-up
Cgmp compliance and regulatory filings
The role involves developing cell line and cell culture strategies to support IND and early clinical development of antibody therapeutics

Job Summary

  • The role involves developing cell line and cell culture strategies to support IND and early clinical development of antibody therapeutics.
  • Candidates must ensure cGMP compliance with ICH guidelines while leading technology transfers between Roche sites and CDMO partners.
  • Roche fosters a culture of personal expression and open dialogue where every voice matters in the mission to prevent, stop, and cure diseases.

Matching Summary

The role involves developing cell line and cell culture strategies to support IND and early clinical development of antibody therapeutics.

Skills & Requirements

Must-have

  • Cell line development strategy execution
  • Mammalian cell culture process scale-up
  • cGMP compliance and regulatory filings
  • Technology transfer to CDMO partners
  • Transient CHO expression and purification

Nice-to-have

  • Experience with N-glycosylation adjustment
  • Familiarity with USP EP BP pharmacopoeia
  • Statistical experimental design software skills
  • Due diligence for in-licensing assets
  • Strong multidisciplinary team collaboration

Key Requirements

  • Ph.D. in Biology or related field with 5+ years experience
  • MS in related field with 8+ years experience
  • Hands-on bioreactor and mammalian cell culture expertise
  • Knowledge of BLA MAA IND regulatory filings

Work Rights

Not specified

Tailored Resume

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