Hiring: (Associate) Director, Drug Product Operations Company: insitro Location: South San Francisco, CA Job Posted Time: 2026-09-03 10:27:05 Employment Type: Remote About the job Experience: •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 Required Skills: •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. •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 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 •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 •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 •Paid parental leave of at least 16 weeks to support parents who give birth, and 10 weeks for a new parent Compensation: •$193,000 - $246,000 / year •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!