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Vice President, CMC
Title:Vice President, CMC

The VP, CMC will be responsible for leading CMC-related activities across the company portfolio of projects including process chemistry and route development, chemical manufacturing, pre-formulation, formulation, analytical development, manufacture and supply of clinical trial materials, and product registration.

Responsibilities include:

  • Overall responsibility for all drug substance and drug product activities from preclinical development through clinical supplies for Phase 3 registration studies and eventual transition to commercial supply
  • Identification, selection and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs
  • Develop and implement strategy for optimizing and controlling quality of bulk API and DP using CROs and CMOs
  • Delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations appropriate for use in clinical trials
  • Projection of API and DP needs for preclinical and clinical programs (with clinical team), development and scale-up activities, and managing associated budgets
  • Formulation design/development for clinical programs and collaborate with others in establishing a supply chain for clinical trial materials
  • Direct efforts to  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
  • Through CROs and CDMOs Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
  • Direct the writing and reviewing documents for INDs, NDAs and other regulatory section submissions; represent the company as the CMC expert before U.S. and European regulatory authorities
  • Review CMC regulatory and Quality documents

Successful candidates will be able to demonstrate:

  • Substantial experience in managing US and International CRO/CMOs for the manufacture of cGMP APIs and DP
  • Substantial experience with projects in clinical development e.g. Phase 1 through Phase 3 including multiple pharmaceutical dosage forms (e.g. parenteral products and solid oral dosages.)
  • Experienced with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations
  • At least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment
  • PhD or MS with 10+ years of experience; Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related scientific discipline
  • 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)

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