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.
The Company:
Based in Central London, our client is a clinical stage biotechnology company developing and discovering drugs with a focus on autoimmune disease.
Location:
Central London - this is a remote/ home based with onsite presence required once a month
The Role:
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
Responsibilities:
- 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
Your Background:
- 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
Apply:
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
