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ai gmp hplc cdmo lnp📋 Description
- Lead CMC strategy for siRNA programs, align manufacturing plans with timelines.
- Drive scale-up and tech transfer of oligonucleotide DP processes (HPLC, TFF) under GMP.
- Advance DP development with formulation and LNP encapsulation; risk assessments.
- Oversee CDMOs, lead campaigns, manage deviations, ensure quality and regulatory alignment.
- Integrate AI-enabled data analysis and digital tools into CMC to accelerate timelines.
🎯 Requirements
- BS/MS/PhD in Chemical Engineering, Biochemistry, or Pharmaceutical Sciences.
- 12+ years in CMC development in biotech with siRNA/oligonucleotide RNA therapeutics.
- Expertise in oligonucleotide drug substance manufacturing, scale-up, GMP transfer.
- Experience overseeing CDMO partnerships and external manufacturing in clinical-stage programs.
- Strong knowledge of global regulatory expectations for CMC documentation and IND/early programs.
- Excellent technical writing and communication; ability to influence cross-functional teams.
🎁 Benefits
- Flexible hybrid work options
- Competitive compensation
- Comprehensive health benefits and wellness programs
- Modern offices in South San Francisco
- Inclusive, diverse environment
- Reasonable accommodation for disabilities
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