Director, siRNA CMC - Opens in new tab

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

Job summary

Osanni Bio, Inc. in San Francisco seeks a Director, siRNA CMC to lead end-to-end CMC strategy for Drug Substance and Drug Product. This role sits in Technical Operations and drives external manufacturing networks enabling programs to advance to clinic.

The ideal candidate brings deep siRNA CMC expertise, IND experience, CDMO leadership, and a proven ability to manage risk, budget, and cross-functional collaboration in a fast-paced biotech environment.

Qualifications

• Must have strong CMC leadership experience in biotech/pharma.
• Direct experience with DS/DP development and regulatory submissions.
• Experience overseeing CDMOs, tech transfer and manufacturing.
• Proven track record in IND filings and Phase 1/2 programs.

Responsibilities

• Own end-to-end CMC strategy and execution for siRNA DS and DP.
• Lead technical oversight of all DS/DP CDMOs and tech transfer.
• Develop phase-appropriate analytical methods and control strategies.
• Author/review CMC sections of IND and filings.
• Partner with Quality on GMP activities and vendor oversight.
• Mitigate technical risks and drive cross-functional decisions.
• Contribute to Technical Operations budgeting and resource planning.

Skills

CMC leadership

Biotech expertise

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Chemistry or related field

MS/PhD preferred

Tools

CDMO management

GMP knowledge

IND authoring experience

Job description

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.

Our Values:

Osanni is guided by three core values: Integrity + Impact, because we give a hoot; Agility + Accountability, so we swoop and soar; and Collaboration + Connection, to be one Osanni Flock. Together, they shape how our team shows up for patients, for each other, and for the mission.

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.

#LI-hybrid

Below is the expected base pay range for this position 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.

Base Pay

$200,000 - $230,000 USD

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!