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Salary: USD 193,000 - 246,000 / annual
insitro is a physical AI company developing a Virtual Human™ platform to unlock causal human biology and accelerate drug discovery. The company combines computational biology with wet-lab validation to identify novel genetic intervention points, then translates these into therapeutics (small molecules, biologics, oligonucleotides) via its TherML™ platform. With multiple programs in metabolic disease and neuroscience advancing toward the clinic and an IND submission planned for late 2026, the company is at a critical inflection point.
The Director of Drug Product Operations will lead drug product strategy and execution across the early-stage pipeline, from preclinical through first-in-human and Phase 2. This is a foundational role as insitro enters its first clinical programs. Key responsibilities include defining formulation and drug product process development strategies, managing fill/finish and container selection, overseeing CDMO partnerships and vendor relationships, authoring CMC sections for IND and Phase 2 regulatory filings, and resolving early-phase health authority questions. The role bridges drug substance, analytical, regulatory, quality, and clinical operations teams to identify and mitigate cross-functional risks.
The successful candidate will own technical budgets and timelines across a growing portfolio of early-phase programs and will establish foundational formulation processes, vendor relationships, and documentation practices. As the pipeline matures, they will build and lead a small team.
Required qualifications include 10+ years of biopharmaceutical development experience with direct ownership of drug substance/drug product process development and CDMO management for early-phase biologics programs. Candidates must demonstrate a track record of advancing programs from IND-enabling activities through first-in-human dosing into Phase 2. Technical breadth across unit operations (chromatography, ultrafiltration/diafiltration, formulation, aseptic filling of vials, pre-filled syringes, cartridges) is essential, along with working knowledge of analytical sciences and clinical supply chain. Regulatory experience authoring CMC sections and managing health authority interactions is required. CDMO leadership experience from site selection through technology transfer is critical. A B.S., M.S., or Ph.D. in Chemical Engineering, Biological Systems Engineering, or related discipline is required. Familiarity with combination products and delivery devices (pre-filled syringes, autoinjectors) is a plus.
The role reports to the Head of CMC and is based in South San Francisco with a hybrid schedule of three days per week onsite for local candidates. Remote candidates willing to travel as needed will be considered.
