Director, siRNA CMC Strategy & Ops

Osanni Bio; San Francisco (CA); Presencial; USD 200.000 - 230.000; Jornada completa

Descripción de la vacante

Osanni Bio, a development-stage therapeutics company in San Francisco, seeks a Director, siRNA CMC to lead end-to-end CMC strategy for siRNA DS and DP. You will oversee CDMOs, drive phase-appropriate analytical methods, and author CMC sections for INDs, collaborating with Quality on GMP activities.

The role demands deep siRNA CMC expertise, leadership, and urgency in a fast-paced biotech setting. Ideal candidates have 10+ years in biotech/pharma CMC, advanced degree preferred, and a proven track

Formación

• Experience leading CMC strategy for biotech/pharma programs.
• Hands-on siRNA DS/DP development and regulatory support.
• Strong IND experience and CMC regulatory writing.
• Experience managing CDMOs, tech transfer, and scale-up.

Responsabilidades

• Own end-to-end CMC strategy and execution for siRNA DS/DP.
• Lead DS/DP CDMO oversight including process development, manufacturing, tech transfer, investigations and performance management.
• Partner with cross-functional leadership to define analytical methods, specifications and control strategies.
• Author and review CMC sections of regulatory submissions (INDs and subsequent filings).
• Collaborate with Quality on GMP activities including vendor management and batch disposition.

Conocimientos

CMC leadership

SiRNA development

Regulatory submissions

CDMO oversight

GMP knowledge

Educación

Bachelor's degree in Chemistry/Biochemistry/Chemical Engineering

MS or PhD preferred

Descripción del empleo

Osanni Bio, a development-stage therapeutics company in San Francisco, seeks a Director, siRNA CMC to lead end-to-end CMC strategy for siRNA DS and DP. You will oversee CDMOs, drive phase-appropriate analytical methods, and author CMC sections for INDs, collaborating with Quality on GMP activities.

The role demands deep siRNA CMC expertise, leadership, and urgency in a fast-paced biotech setting. Ideal candidates have 10+ years in biotech/pharma CMC, advanced degree preferred, and a proven track