Added
23 minutes ago
Type
Full time
Salary
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Related skills

process development gmp regulatory submissions cgmp cmc

πŸ“‹ Description

  • Lead drug product CMC strategy and execution for small molecule programs from early clinical
  • Direct phase-appropriate formulation and process development for oral solid dosage forms, including
  • Provide technical leadership for technology transfer, process characterization, process validation
  • Select, onboard, and oversee CDMOs and external partners supporting drug product development
  • Establish expectations, work plans, timelines, budgets, and performance measures for external
  • Provide technical oversight of GMP manufacturing campaigns, including batch documentation

🎯 Requirements

  • Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Pharmaceutics, or
  • 10+ years of experience in the pharmaceutical or biotechnology industry.
  • Demonstrated experience leading therapeutic formulation and process development.
  • Technical expertise in formulation development, process development, scale-up, technology transfer
  • Experience supporting drug development through late-stage and commercialization; commercial launch
  • Proven experience managing external partners in a highly outsourced model.

🎁 Benefits

  • Fully remote working environment
  • Full-time position with significant technical and strategic leadership responsibilities
  • Expected salary range: $200,000–$260,000 USD with flexibility
  • Discretionary annual bonus potential
  • Opportunity to lead drug strategy across the development lifecycle
  • Collaboration with CMC, Quality, Regulatory, and program teams
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