Director, siRNA CMC Strategy & CDMO Leadership

Osanni; San Francisco (CA); Hybrid; USD 200,000 - 230,000; Full time

Job summary

Osanni Bio in San Francisco seeks a Director, siRNA CMC to own end-to-end CMC strategy and execution for siRNA Drug Substance and Drug Product. You will establish the external manufacturing network to advance programs from discovery into the clinic.

The ideal candidate brings deep siRNA expertise, strong operational discipline, and CDMO leadership, and will partner with cross-functional teams to define analytical methods, specifications, and control strategies, and to author regulatory CMC

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field; advanced degree preferred.
• 10+ years of CMC experience in biotech or pharma with leadership ownership.
• IND experience and authorship of CMC regulatory sections for Phase 1/2 programs.

Responsibilities

• Own the end-to-end CMC strategy and execution for siRNA DS and DP, ensuring readiness to support Osanni’s development pipeline.
• Lead technical oversight of all DS/DP CDMOs, including process development, tech transfer, and vendor management.
• Partner with cross-functional leadership to establish phase-appropriate analytical methods, specifications, and control strategies.

Skills

CMC leadership

siRNA development

Regulatory submissions (IND)

Vendor management

Cross-functional leadership

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmaceutical Sciences

MS or PhD preferred

Tools

CDMOs management

GMP knowledge

Analytical methods development

Job description

Osanni Bio in San Francisco seeks a Director, siRNA CMC to own end-to-end CMC strategy and execution for siRNA Drug Substance and Drug Product. You will establish the external manufacturing network to advance programs from discovery into the clinic.

The ideal candidate brings deep siRNA expertise, strong operational discipline, and CDMO leadership, and will partner with cross-functional teams to define analytical methods, specifications, and control strategies, and to author regulatory CMC