(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

- De-Risk for Speed: Proactively identify and resolve DP-related bottlenecks that could delay first-in-human or Phase 2 timelines

- CDMO & Vendor Leadership

- Lead CDMO Selection: Own the selection and contracting process for CDMO partners supporting Phase 1/2 clinical drug product manufacturing

- Manage Technical Oversight: Drive day-to-day technical management of CDMO relationships to keep programs on timeline and in spec

- Regulatory & Cross-Functional Partnership

- Author Regulatory Submissions: Write DP CMC sections for INDs and Phase 2 filings, and resolve early-phase health authority questions

- Bridge the Value Chain: Engage upstream with Drug Substance and downstream with clinical supply, labeling, and distribution to catch risks across the full value chain rather than in a single functional silo

- Partner Cross-Functionally: Align formulation and DP strategy with program timelines alongside Drug Substance, Regulatory Affairs, Quality, and Clinical Operations

- Program & Team Building

- Own Budgets & Timelines: Manage DP technical budgets and timelines across a small but growing portfolio of early-phase programs

- Build the Foundation: Establish formulation and DP processes, vendor relationships, and documentation practices, and build a team as the pipeline matures

ABOUT YOU

- Experience & Qualifications

- 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

- Technical Breadth: Working knowledge of DS/DP unit operations (chromatography, UFDF/formulation, aseptic filling of vials, pre-filled syringes, cartridges), with enough fluency in analytical sciences and clinical supply to spot cross-functional risks. Familiarity with combination products …