Added
22 minutes ago
Type
Full time
Salary
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Related skills

process development process validation scale-up technology transfer formulation development

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 transfers, process characterization, process
  • Select, onboard, and provide technical oversight of CDMOs and external partners supporting drug
  • 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 a
  • Demonstrated experience leading formulation and process development of therapeutic products.
  • Strong technical expertise in formulation development, process development, scale-up, process
  • Experience in supporting drug product development from early clinical stages to commercialization
  • Proven success leading CDMO and external manufacturing partners within a highly outsourced
  • Strong working knowledge of drug product manufacturing, pharmaceutical analytical testing and

🎁 Benefits

  • Remote working environments/telecommuting.
  • Full-time, exempt position with, impactful leadership opportunities.
  • An expected salary of $200,000–$260,000 USD, with the expected range depending on the applicant's
  • Potential annual discretionary bonus based on performance.
  • Opportunity to provide vital drug product strategy across clinical development.
  • Access to collaboration with CMC, Quality, Regulatory, Analytical, and supply chain international.
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