(Associate) Director, Drug Product Operations

THE OPPORTUNITY 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 as in formulation and fill/finish. This position 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 with willingness to travel to the office as work necessitates will also be considered. RESPONSIBILITIES - DP Strategy & Process Development - Define FIH & Phase 2 Strategy: Set and execute drug product strategy for first-in-human and Phase 2 studies, including formulation interface, fill/finish, and primary container selection appropriate to early clinical scale and speed - Own Process Development & Tech Transfer: Lead DP process development and technology transfer from development through clinical manufacturing, prioritizing flexibility and speed for early-phase programs