Connect Search is supporting a leading, clinical stage biotech company based in San Diego.
Due to an exciting period of growth and forthcoming commercializations, they require a CMC Director to provide technical oversight for supply of APIs, chemical process R&D and CMC regulatory submissions.
Key responsibilities include:
- Implementing best practice manufacturing models (to GMP and GLP standard) internally and 3rd party R&D, CROs and CDMOs
- Providing guidance and knowledge to internal teams such as Marketing, Business Development, Manufacturing, Supply Chain as well as external 3rd parties to ensure that products are manufactured to the highest standard and comply with all applicable regulations
- Leading the regulatory submissions and seen as the key interface between the business and regulatory agencies
- Ensure that all internal departments are coherent with current regulations, operating models, processes, policies, and market opportunities
- Sanction GLP and GMP models and regulations
To be considered for this opportunity you MUST have:
- Ph.D or Masters in Chemical Engineering or related
- Experience of Worldwide regulations, knowledge of current industry manufacturing best practices
- Experience of managing CMOs, Manufacturing, Supply Chains, and Regulatory CMC for commercialization stages
- Ability to lead cross functional teams (internal and external)
Apply now for immediate consideration.