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Senior Principal Scientist: Process Chemistry

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Proclinical

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Location:
United States , Palo Alto

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Lead the chemistry behind tomorrow's medicines by driving world‑class drug substance development from concept to GMP production. We are seeking an experienced process chemist to provide technical leadership for outsourced drug substance development and manufacturing.

Job Responsibility:

  • Serve as the technical point of accountability for drug substance programs, ensuring alignment across CMC, Quality, Regulatory, and external partners
  • Lead route selection, process development, optimization, and impurity control strategies
  • Lead and manage CDMOs from proposal evaluation and selection through GMP manufacturing, release, and delivery
  • Characterize drug substance properties and support form selection activities
  • Review and approve batch records and oversee external manufacturing quality and compliance
  • Troubleshoot process issues and drive continuous improvement initiatives with internal and external teams
  • Prepare comprehensive tech transfer packages and support analytical method development
  • Guide chemical development strategy from early-stage programs through commercialization
  • Author and review technical sections for IND, IMPD, and other global regulatory submissions
  • Partner with Project Management and Finance to support cost, timeline, and risk management for drug substance programs

Requirements:

  • Ph.D. in Organic Chemistry with 8+ years of relevant industry experience in process chemistry
  • Strong expertise in synthetic chemistry, scale-up, and cGMP manufacturing
  • Working knowledge of QbD principles, PAT, risk management, and regulatory expectations
  • Proven experience managing CDMOs and CROs
  • Demonstrated ability to operate independently and influence cross-functional teams in a fast-paced development environment
  • Excellent problem-solving, communication, and project management skills
  • Up to ~20% travel, primarily to CDMO sites

Additional Information:

Job Posted:
February 14, 2026

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