VenatoRx Careers
Job Openings >> Vice President, CMC
Vice President, CMC
Summary
Title:Vice President, CMC
ID:1019
Description

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)

Alternatively, you can apply to this job using your profile on one of the following sites:

Powered by ApplicantStack