CK Group are recruiting for a Vice President of CMC to join a growing clinical-stage biotech company who are focused on improving the lives of patients facing life threatening disease with the next generation of antibody therapies.
Our client based in Woburn, Massachusetts and are looking to recruit a VP of CMC on a permanent basis.
Vice President of CMC Role:
The Vice President, CMC will be responsible for all CMC activities, as well as, all outsourced contract manufacturing for programs in different stages of development ranging from GLP toxicology materials to Phase 1 to Phase 2 clinical trial material and commercial drug products.
Further duties include to:
- Establish and oversee the implementation of the overall CMC strategy for all stages of programs ranging from preclinical GLP studies through Ph3 clinical trials.
- Review CMC project plans and timelines and assist in execution to ensure all projects are appropriately prioritized and key goals are met on time.
- Develop and maintain an in-depth knowledge of drug product manufacturing and development technology; and the associated regulatory requirements.
- Author and review CMC regulatory submissions.
- Advanced degree in Engineering, Pharmaceutical Sciences, or related field.
- Extensive experience with development and optimization of manufacturing processes and oversight of manufacturing campaigns for supplies ranging from GLP toxicology supplies to cGMP Phase 3 clinical trial material.
- A strong understanding of CFR Parts 58, 210, and 211; ICH; and FDA regulatory guidance related to pharmaceutical development, manufacturing and specifications is required.
- Previous extensive experience in management of process development and drug product manufacturing is required.
For more information or to apply for this Vice President/Head of CMC position, please contact Alex Tosney by email at firstname.lastname@example.org, quoting job ref 51405.
It is essential that applicants hold entitlement to work in the USA.