Director, siRNA CMC — End-to-End DS/DP Lead

Osanni Bio; San Francisco (CA); Sur place; USD 200 000 - 230 000; Plein temps

Résumé du poste

Osanni Bio in San Francisco, CA, seeks a Director of siRNA CMC to lead end-to-end strategy and execution for drug substance and product. You will supervise DS/DP through development, tech transfer, and regulatory filing processes in a fast-paced biotech setting.

The ideal candidate has 10+ years in CMC with siRNA programs, strong GMP/QA background, and a track record partnering with CDMOs and cross-functional teams. Base pay is substantial, with a comprehensive benefits package.

Qualifications

• Bachelor's degree required in a related field; advanced degree preferred.
• 10+ years of CMC experience in biotech or pharma, with leadership ownership.
• IND experience and CMC regulatory writing for Phase 1/2 programs.
• Extensive GMP/QA experience and CDMO/vendor oversight.

Responsabilités

• Own end-to-end CMC strategy and execution for siRNA DS/DP.
• Oversee DS/DP CDMOs, tech transfer, investigations, performance management.
• Establish phase-appropriate analytical methods, specs, control strategies.
• Author/regulatory submissions (IND and filings).
• Partner with Quality on GMP activities, including vendor management.
• Identify/mitigate technical risks and drive cross-functional decisions.
• Contribute to budget planning, resource allocation, and vendor contracting.

Connaissances

siRNA development

CMC leadership

IND experience

Regulatory submissions

Vendor management

Quality systems

Formation

MS or PhD preferred

Bachelor's degree in Chemistry/Biochemistry/Pharma

Description du poste

Osanni Bio in San Francisco, CA, seeks a Director of siRNA CMC to lead end-to-end strategy and execution for drug substance and product. You will supervise DS/DP through development, tech transfer, and regulatory filing processes in a fast-paced biotech setting.

The ideal candidate has 10+ years in CMC with siRNA programs, strong GMP/QA background, and a track record partnering with CDMOs and cross-functional teams. Base pay is substantial, with a comprehensive benefits package.