(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 and delivery devices relevant to early clinical studies (pre-filled syringes, autoinjectors) is a plus - **Regulatory Acumen:** Direct experience authoring CMC sections for INDs and resolving early-phase health authority questions - **CDMO Leadership:** Experience as a vendor/CDMO relationship leader for clinical-scale manufacturing, from site selection through technology transfer - **Education:** B.S., M.S., or Ph.D. in Chemical Engineering, Biological Systems Engineering, or a related discipline ## **Compensation & Benefits at insitro** Our target starting salary for successful US-based applicants for this role is $193,000 - $246,000. To determine starting pay, we consider multiple job-related factors including a candidate's skills, education and experience, market demand, business needs, and internal parity. We may also adjust this range in the future based on market data. This role is eligible for participation in our Annual Performance Bonus Plan (based on company targets by role level and annual company performance) and our Equity Incentive Plan, subject to the terms of those plans and associated policies. In addition, insitro also provides our employees: - 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 insitro is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We believe diversity, equity, and inclusion need to be at the foundation of our culture. We work hard to bring together diverse teams–grounded in a wide range of expertise and life experiences–and work even harder to ensure those teams thrive in inclusive, growth-oriented environments supported by equitable company and team practices. All candidates can expect equitable treatment, respect, and fairness throughout the interview process. *Please be aware of recruitment scams: we never request payments, all recruitment communications are from @*[**](http://insitro.com)*, and if in doubt, contact us at* [*info@insitro.com*](mailto:info@insitro.com)*.* #LI-Hybrid **About insitro** insitro is a drug discovery and development company using machine learning (ML) and data at scale to decode biology for transformative medicines. At the core of insitro’s approach is the convergence of in-house generated multi-modal cellular data and high-content phenotypic human cohort data. We rely on these data to develop ML-driven, predictive disease models that uncover underlying biologic state and elucidate critical drivers of disease. These powerful models rely on extensive biological and computational infrastructure and allow insitro to advance novel targets and patient biomarkers, design therapeutics and inform clinical strategy. insitro is advancing a wholly owned and partnered pipeline of insights and therapeutics in neuroscience and metabolism. Since launching in 2018, insitro has raised over $700 million from top tech, biotech and crossover investors, and from collaborations with pharmaceutical partners. For more information on insitro, please visit [](http://www.insitro.com).