CK Group are recruiting for a CMC Director to join an exciting innovative drug discovery company in the biotechnology industry. This is a remote/home based role.
Based in Central London, our client is a clinical stage biotechnology company developing and discovering drugs with a focus on autoimmune disease.
Central London - this is a remote/ home based with onsite presence required once a month
To lead, plan and execute the chemistry, manufacturing, and controls (CMC) strategy for our clients pipeline products. Acting as CMC subject matter expert, you will have responsibility for hands-on management of CMC activities including selection of manufacturers, drug substance development and manufacture, drug product formulation development and manufacture
- Develop CMC plans for all projects, with focus on drug substance and drug product scale-up and commercial manufacture with CDMOs
- Provide strong technical leadership and activity management of CDMOs to ensure drug substance manufacture and drug product development activities follow cGMP requirements.
- To oversee and manage CDMOs in production of early-stage drug product for GLP studies and early clinical trials to cGMP
- Anticipate future manufacturing, development CMC program requirements, prepare budget forecasts and to manage budgets
- Collaborate closely with cross-functional team members from different functions, and partner with multiple CDMOs and contract laboratory organisations
- PhD with 10+ years? experience in CMC development.
- Strong technical knowledge in CMC drug substance, and drug product development of small molecule NCE products, including scale-up and commercial manufacture.
- Experienced in outsourced development including management and oversight of CROs, CDMOs and contract laboratories
- Ability to function as hands-on CMC Program Lead and key point of contact to CMOs to manage process/analytical development, validation, specifications, manufacturing and release of API and drug product
- Strong knowledge in regulatory CMC (US FDA, EMA and MHRA), and successful track record of delivering high quality, compliant CMC components of dossiers
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55685 in all correspondence.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Reference: 55685
Website: CK Group
- Posted: 8th September 2023
- Expires: 6th October 2023