(Associate) Director, Drug Product Operations
About The Position
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.
Requirements
- 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
- Demonstrated success taking programs from IND-enabling activities through first-in-human dosing and into Phase 2
- 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.
- Direct experience authoring CMC sections for INDs and resolving early-phase health authority questions
- Experience as a vendor/CDMO relationship leader for clinical-scale manufacturing, from site selection through technology transfer
- B.S., M.S., or Ph.D. in Chemical Engineering, Biological Systems Engineering, or a related discipline
Nice To Haves
- Familiarity with combination products and delivery devices relevant to early clinical studies (pre-filled syringes, autoinjectors) is a plus
Responsibilities
- 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
- 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
- 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
- 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
Benefits
- Annual Performance Bonus Plan
- Equity Incentive Plan
- 401(k) plan with employer matching for contributions
- Excellent medical, dental, and vision coverage as well as mental health and well-being support
- Open, flexible vacation policy
- Paid parental leave of at least 16 weeks to support parents who give birth, and 10 weeks for a new parent (inclusive of birth, adoption, fostering, etc)
- Quarterly budget for books and online courses for self-development
- New hire stipend for home office setup
- Monthly cell phone & internet stipend
- Access to free onsite baristas and daily lunch for employees who are either onsite or hybrid
- Access to a free commuter bus network that provides transport to and from our South San Francisco HQ from locations all around the Bay Area
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What This Job Offers
Job Type
Full-time
Career Level
Senior
