Head of Chemistry Manufacturing and Controls - Remote Position (JLBCMC) Colorado, USA
Remote position for Head of Chemistry Manufacturing and Controls. The CMC leader will be responsible for CMC-related activities across the portfolio including process chemistry and route development, chemical manufacturing, pre-formulation, formulation and manufacture and supply of clinical trial materials. The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.
Principal Duties and Responsibilities
- Overall responsibility for all drug substance and drug product activities from preclinical development through clinical supplies for Phase 3 registration studies
- 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 and DOE (design of experimentation) 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 that meet or exceed the target clinical profile
- Projection of API and DP needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance team)
- Formulation design/development for clinical programs
- Management of supply chain and logistics in support of clinical studies
- In coordination with Quality Assurance, 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
- Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
- Writing and reviewing documents for INDs / regulatory section 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
Skills and Background
- 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. tablets, capsules, topicals, etc.)
- 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
- Experience in supply chain management.
- PhD or MS with 10+ years of experience; Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
- 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)
To be considered, please apply with a resume. For additional information on this opportunity, contact Jessica Bratrud directly at 605.705.4867. Resumes may be confidentially sent to jessica.bratrud@gogpac.com.