(Associate) Director, Drug Product Operations

Insitro
United States
Workplace: HybridFull timeUSD 193,000 - 246,000 annuallyFunction: Executive & General ManagementExperience: 10+ yearsEducation: bachelorsSkills: ["Leadership","Cross-functional partnership","Risk identification","Technical oversight","Strategic planning"]

Lead drug product strategy and execution for early-stage programs, owning formulation and DP process development from pre-clinical through first-in-human and into Phase 2. Drive fill/finish and primary container selection, technology transfer, and de-risk DP timelines for speed and quality. Select and oversee CDMO partners for clinical drug product manufacturing, author DP CMC sections for IND and Phase 2 filings, and collaborate cross-functionally across CMC, Regulatory, Quality, and Clinical Operations while managing budgets and building the team.

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Insitro
Insitro
1 day ago

(Associate) Director, Drug Product Operations

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Last checked: 8 hours agoStatus: Live

Job Summary

Lead drug product strategy and execution for early-stage programs, owning formulation and DP process development from pre-clinical through first-in-human and into Phase 2. Drive fill/finish and primary container selection, technology transfer, and de-risk DP timelines for speed and quality. Select and oversee CDMO partners for clinical drug product manufacturing, author DP CMC sections for IND and Phase 2 filings, and collaborate cross-functionally across CMC, Regulatory, Quality, and Clinical Operations while managing budgets and building the team.
Location: United States
Workplace: Hybrid
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Director level

Key Responsibilities

  • •Define FIH and Phase 2 drug product strategy, including formulation interface, fill/finish, and primary container selection for early clinical scale.
  • •Own DP process development and technology transfer from development through clinical manufacturing, prioritizing flexibility and speed.
  • •Identify and resolve DP-related bottlenecks that could delay first-in-human or Phase 2 timelines.
  • •Lead CDMO partner selection and contracting for Phase 1/2 clinical drug product manufacturing, and provide day-to-day technical oversight to keep programs on timeline and in spec.
  • •Write DP CMC sections for INDs and Phase 2 filings, and align formulation/DP strategy with Drug Substance, Regulatory, Quality, and Clinical Operations while managing DP budgets and timelines.

Pay and Benefits

Salary: USD 193,000 - 246,000 annually
Equity and Bonus:Equity
Perks:401kHealth InsuranceDentalVisionPaid ParentalLearning BudgetHome OfficeCell PhoneCommuter Benefits

Key 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.
  • •Experience taking programs from IND-enabling activities through first-in-human dosing and into Phase 2.
  • •Working knowledge of DS/DP unit operations including chromatography, UFDF/formulation, and aseptic filling methods for vials, pre-filled syringes, and cartridges.
  • •Direct experience authoring CMC sections for INDs and resolving early-phase health authority questions.
  • •B.S., M.S., or Ph.D. in Chemical Engineering, Biological Systems Engineering, or a related discipline.
Experience:10+ yearsBiopharmaceutical developmentBiologicsCMCCDMOIND-enabling
Education:Bachelor's in Chemical Engineering, Biological Systems Engineering, or a related discipline
Skills:LeadershipCross-functional partnershipRisk identificationTechnical oversightStrategic planning
Tech Stack:ChromatographyUFDFAseptic fillingPre-filled syringesAutoinjectorsCartridgesCombination products

Company Brief

Insitro
Insitro is a machine-learning-driven drug discovery and development company that integrates high-throughput biology, human genetics, and AI to identify therapeutic targets and design medicines across metabolic and neurodegenerative diseases.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Scaleup
Funding: Series C
Headquarters: South San Francisco, United States
Founded: 2018
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