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Remote - Principal Scientist / Director - Analytical MSAT - Cell - Based Assay's Life Cycle
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- Provide support for the management of outsourced analytical methods across a global network of vendors involved in the manufacturing of commercial and clinical Cell Therapy/mAb based drug substances and drug products.
- Provide oversight and expertise for external manufacturing operations relating to bioassays such as ADCC, CDC, ELISA, SPR, ELISA, ELISPots, etc.
- Contribute to the preparation and review of CMC (Chemistry, Manufacturing, and Controls) documentation, particularly focusing on the analytical sections required for regulatory filings(BLA/MAA), including post-approval submissions to US and EU regulatory bodies.
- 4+ years of experience in Analytical Development for Cell Therapy or Protein based products, industry is preferred (M.S. with significant industry experience will also be considered)
- Experience managing the entire cell-based assay lifecycle from development, Tech transfer, to commercial and being involved in the BLA/MAA regulatory submissions.
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