(Associate) Director, Drug Product Operations

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. 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. The (Associate) Director, Drug Product Operations will own the formulation and drug product strategy for our early-stage pipeline, driving execution from pre-clinical through first-in-human and into Phase

2. This role involves owning the end-to-end development and transfer of fill/finish processes while proactively de-risking timelines across the drug product value chain. You will lead the selection and oversight of CDMO partners and manage the technical execution of drug product manufacturing for clinical programs. This is a foundational position that requires fluency across drug substance, analytical, and supply chain discussions to ensure alignment with regulatory and clinical timelines.

Key facts

What you'll do

• Define first-in-human and Phase 2 drug product strategy, including formulation interface, fill/finish, and primary container selection appropriate to early clinical scale and speed.
• Lead drug product process development and technology transfer from development through clinical manufacturing, prioritizing flexibility and speed for early-phase programs.
• Proactively identify and resolve drug product-related bottlenecks that could delay first-in-human or Phase 2 timelines.
• Own the selection and contracting process for clinical-scale CDMO partners supporting Phase 1/2 drug product manufacturing.
• Drive day-to-day technical management of CDMO relationships to keep programs on timeline and within specification.
• Write drug product CMC sections for INDs and Phase 2 filings, and resolve early-phase health authority questions.
• Engage upstream with Drug Substance and downstream with clinical supply, labeling, and distribution to catch cross-functional risks across the full value chain.
• Align formulation and drug product strategy with program timelines in partnership with Drug Substance, Regulatory Affairs, Quality, and Clinical Operations.
• Manage drug product technical budgets and timelines across a small but growing portfolio of early-phase programs.
• Establish formulation and drug product processes, vendor relationships, and documentation practices while building the team as the pipeline matures.

Requirements

• Bring 10+ years of biopharmaceutical development experience, with direct ownership of drug substance and drug product process development and CDMO management for early-phase (Phase 1/2) biologics programs.
• Demonstrate a track record of taking programs from IND-enabling activities through first-in-human dosing and into Phase 2.
• Maintain a working knowledge of drug substance and drug product unit operations, including chromatography, ultrafiltration/diafiltration, formulation, aseptic filling of vials, pre-filled syringes, and cartridges.
• Ensure enough fluency in analytical sciences and clinical supply to spot cross-functional risks and engage effectively with specialists.
• Apply direct experience authoring CMC sections for INDs and resolving early-phase health authority questions.
• Leverage experience as a vendor or CDMO relationship leader for clinical-scale manufacturing, from site selection through technology transfer.
• Hold a B.S., M.S., or Ph.D. in Chemical Engineering, Biological Systems Engineering, or a related discipline.
• Operate with the versatility to work across small programs and early-phase portfolios while maintaining rigorous process standards.
• Navigate regulatory expectations for early-phase drug product development with confidence and precision.
• Collaborate effectively across functions to maintain alignment on timelines, specifications, and risk mitigation.

Nice to have

• Familiarity with combination products and delivery devices relevant to early clinical studies, such as pre-filled syringes, autoinjectors, and cartridges.

Practical notes

This role is based in South San Francisco, California. The position is full-time and eligible for participation in Insitro's compensation and benefits programs. Hybrid schedules include three days per week onsite for local candidates; remote candidates with willingness to travel to the office as work necessitates will also be considered. There are no specified travel requirements, visa sponsorships, or application deadlines outlined in this description.