Director, siRNA CMC

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 is a development-stage therapeutics platform, headquartered in San Francisco, California. We are creative and agile innovators, relentlessly curious about finding new ways to target the biology behind diseases with the greatest unmet need and determined to do something about it.

At the center of Osanni is its innovation engine, which is optimized for discovering new scientific insights, designing novel drug concepts, and efficiently advancing programs to a meaningful proof-of-concept. Once a program is sufficiently de-risked, it graduates into its ecosystem of affiliate companies, which are equipped with the dedicated focus, specialized talent and support necessary to scale. Osanni’s architecture marries the scientific depth and operational power of a centralized platform with the speed, agility and accountability of independent companies. The result: an opportunity to create and deliver more transformative medicines.

We hold patients and the physicians who care for them as our North Star. It guides our purpose, sharpens our decision-making, and defines our impact. Osanni is currently advancing programs in ophthalmology, cardiology and beyond. We are building a highly skilled team, passionate about having an impact on human health. Be part of creating an organization where people enjoy their work and their colleagues, are valued for their individuality, and can't imagine working anywhere else.

About the Role:

The Director, siRNA CMC is responsible for the end-to-end CMC strategy and execution for siRNA Drug Substance (DS) and Drug Product (DP). As a key member of the Technical Operations team, you will establish the CMC strategy and external manufacturing network that enables Osanni's siRNA programs to advance from discovery into the clinic.

The ideal candidate is a siRNA subject matter expert who combines deep technical judgment with strong operational discipline and CDMO leadership. They are comfortable moving fluidly between strategy and day-to-day execution, thrive on solving complex challenges, and communicate clearly with scientific, quality, and regulatory stakeholders. Above all, they bring the adaptability, ownership mindset, and sense of urgency needed to succeed in Osanni's fast-paced, evolving biotech environment.

What You Will Do:

• 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 and DP CDMOs, including process development, manufacturing, tech transfer, investigations, and performance management, serving as the primary technical point of accountability.
• Partner with cross-functional leadership to establish phase-appropriate analytical methods, specifications, and control strategies for siRNA products.
• Author and review the CMC sections of regulatory submissions (IND and subsequent filings).
• Partner with Quality on all GMP activities, including but not limited to vendor management and oversight, batch disposition, deviations, change controls, etc.
• Identify and mitigate technical risks, escalating issues and driving cross-functional decisions to keep programs on track.
• Contribute to Technical Operations budget planning, resource allocation, and vendor contracting in partnership with Finance and Program Leadership.

What You Bring:

• Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field; advanced degree (MS or PhD) preferred.
• 10+ years of CMC experience in biotech or pharma (with an advanced degree, 8+ years), including significant time in a leadership or technical ownership role.
• Deep technical expertise in siRNA development, with direct, hands-on experience across both DS and DP. Considerable familiarity with siRNA analytical methods and control strategies, including method development, specifications, and phase-appropriate testing.
• Demonstrated IND experience and authorship of CMC regulatory sections, with a strong track record supporting Phase 1 and Phase 2 programs (Phase 3 and commercial experience a plus).
• Extensive manufacturing plant experience, either managing CDMOs or working within a CDMO or manufacturing organization, including technology transfer, scale-up, and campaign management. Excellent vendor and relationship management skills, with the ability to hold external partners accountable for quality, timelines, and cost.
• Strong understanding of GMP requirements, quality systems, and phase-appropriate control strategies for oligonucleotide or complex modality products.

The expected base pay range for this position is $200,000 - $230,000 plus bonus and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

We will provide an intellectually stimulating, collegial and fast-paced environment. If you are ready to be a part of building the future of transformative medicines, then we are excited to hear from you!