At insitro, we are building a different kind of drug company to bring better drugs faster to the patients who can benefit most. Through the power of machine learning (ML) and data at scale, we decode the complexities of biology to unlock transformative new... Backed by SoftBank VF, a16z and GV.
About the role
insitro is a physical AI company dedicated to unlocking causal human biology and accelerating the delivery of better medicines to patients. Our unique Virtual Human™ platform identifies novel, high-impact genetic intervention points, which our TherML™ platform translates into therapeutics—whether small molecules, biologics, or oligos.
What they're looking for
- Proven Tenure: 10+ years of biopharmaceutical development experience, with direct ownership of DS/DP process development and CDMO management for early-phase (Phase 1/2) biologics programs
- Track Record: Demonstrated success taking programs from IND-enabling activities through first-in-human dosing and into Phase 2
- Regulatory Acumen: Direct experience authoring CMC sections for INDs and resolving early-phase health authority questions
- CDMO Leadership: Experience as a vendor/CDMO relationship leader for clinical-scale manufacturing, from site selection through technology transfer
- Education: B.S., M.S., or Ph.D. in Chemical Engineering, Biological Systems Engineering, or a related discipline
More about this role
insitro is a physical AI company dedicated to unlocking causal human biology and accelerating the delivery of better medicines to patients. Our unique Virtual Human™ platform identifies novel, high-impact genetic intervention points, which our TherML™ platform translates into therapeutics—whether small molecules, biologics, or oligos. With multiple programs in metabolic disease and neuroscience advancing toward the clinic, and our first IND submission slated for the second half of this year, we are at a pivotal inflection point.
insitro is seeking an (Associate) Director, Drug Product Operations to lead drug product strategy and execution for our early-stage pipeline, from pre-clinical through first-in-human and beyond. This is a foundational role for a company entering its first clinical programs: you'll own formulation and DP process development, fill/finish, and CDMO partnerships at early-clinical scale, working closely with other CMC roles, Regulatory, and Clinical Operations. Because our pipeline and team are still growing, we need someone with broad, hands-on fluency across the CMC value chain — equally comfortable in drug substance, analytical, and supply chain discussions...
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