Head of Chemistry Manufacturing and Controls (CMC)« back

Position Summary:

The CMC leader will build and lead a group responsible for CMC-related activities across the portfolio including process chemistry and route development, scale-up efforts during lead optimization, chemical manufacturing, pre-formulation, formulation and manufacture and supply of clinical trial materials. The ideal candidate will be a highly motivated leader with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

Responsibilities

  • Overall responsibility for all drug substance and drug product activities from preclinical development through commercialization
  • Identification, selection and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture of Drug Substance (API) and formulation development and cGMP manufacture of Drug Product (DP) in support of ongoing clinical programs
  • Delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile
  • Implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
  • Projection of API and DP needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance team)
  • Management of supply chain and logistics in support of clinical studies
  • Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
  • Prepare and/or review CMC sections of INDs, CTAs, NDAs, MAAs and other regulatory submissions; represent the company as the CMC expert before U.S. and European regulatory authorities
  • Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents
  • Prepare technical reports, publications and oral presentations

Qualifications

  • PhD or MS with 10+ years of experience; Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
  • At least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment
  • Substantial experience leveraging US and International CRO/CMOs for the manufacture of cGMP APIs and DP to meet aggressive timelines
  • Substantial experience with projects in clinical development e.g. Phase 1 through Phase 3 including multiple pharmaceutical dosage forms (e.g. tablets, capsules, topicals, etc.)
  • Experienced with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations
  • Experience in supply chain management.
  • Able to identify and resolve critical issues
  • Experience implementing technical, strategic and operational plans
  • Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
  • Qualities of servant leadership and self-awareness required

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