Associate Director, Chemical Development

3 weeks ago

South San Francisco, United States Enigma Search Full time

The Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the companys pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to ensure CMC activities are executed seamlessly and in alignment with the clinical development plans and timelines. The candidate will contribute to the overall CMC strategy, oversee planning, and execution; provide regulatory documentation for early phases of clinical trials; and participate in managing other CDMO areas, including analytical and drug product manufacturing.

This is a full-time permanent position based in South San Francisco, CA.

Responsibilities:

  • Develop chemical processes for manufacturing small-molecule drug substances
  • Lead process development and drug substance manufacturing activities at external labs and manufacturing facilities
  • Manage and maintain project timelines for CMC activities in support of clinical development activities
  • Contribute to develop target drug substance profile and specifications
  • Screen and select external partners for process research, non-GMP and GMP production of drug substances
  • Oversee tech transfer and process validation of drug substance manufacturing processes
  • Design, review, and approve of study protocols, development reports, and manufacturing batch records, and manage master production records and specifications
  • Review proposals, negotiate prices, recommend suppliers, verify delivery, manage contracts, and maintain necessary records
  • Identify and facilitate procurement of raw materials needed for drug substance manufacturing activities
  • Collaborate with cross-functional pre-clinical, clinical development, and clinical operations teams to ensure CMC and program goals are met
  • Work closely with CMC Analytical, Formulations, Quality Assurance and Regulatory teams
  • Author, review and approve relevant CMC sections for regulatory submissions
  • Represent the CMC team to communicate CMC strategy and project status to key stakeholders cross-functionally and assist in driving decision-making

Requirements:

  • Ph.D. degree in Chemistry, Chemical Engineering, or related scientific field
  • 10+ years of industry experience in small-molecule drug substance chemical development and manufacturing
  • Direct experience with management of CMOs in small-molecule drug substance manufacturing
  • Thorough understanding and knowledge of industry practices in drug substance manufacturing and supply
  • Strong knowledge of GMP regulations and compliance
  • A proven track record in chemical process development from R&D to late-stage development
  • Good understanding and knowledge of analytical methods and related issues
  • Familiar with basic formulations is highly desirable
  • Experience in writing CMC sections for regulatory submissions and documentation
  • Strong organizational and planning skills, with ability to balance multiple deliverables and responsibilities
  • Excellent written and verbal communication skills
  • Ability to work collaboratively in a team environment with internal and external partners

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