Director of Manufacturing
Recruiter: Hays Recruitment
Application date: 16th Nov 2020
My client, an innovative rapidly expanding Oxford-based, clinical-stage biotech company of who are looking for a senior candidate join their leadership team and to establish and manage the manufacturing unit for the production of material of clinical quality to cGMP standards for toxicology studies and early clinical trials.
They are looking for senior candidates with extensive working experience within a cGMP field, with strong knowledge and experience with Phase 1/2 clinical trials, preferably with managerial experience. The successful candidate will be expected to oversee, plan and manage the finalisation of installation, equipping, and qualification (validation) of their Manufacturing Unit. Also, they will be expected to manufacture material suitable for toxicity trials and Phase 1/2 clinical trials. These materials will be used to produce synthetic vaccines so previous experience with ATMPs, small molecules or viral vectors would be beneficial.
This role presents an exciting opportunity for a highly experienced and competent professional, of whom is looking to share their wealth of knowledge and head up a brand-new manufacturing unit.
• To oversee, plan and manage the finalisation of installation, equipping, and qualification (validation) of the Abingdon Manufacturing Unit.
• To define the process and process operations to cGMP standards.
• To develop manufacturing procedures written instructions (SOPs and Process instructions) together with recording systems to meet data integrity standards.
• To demonstrate that the manufacturing operation produces material to a standard required for a cGMP certificate and the granting of a manufacturing licence for investigational medical products.
• To manufacture material suitable for toxicity trials and Phase 1/2 clinical trials
• To develop a global procurement strategy for the raw materials the company uses and manage contractors responsible for supplying cGMP materials.
• Coordinate with the company R&D department to facilitate process development and tech transfer work as required, without compromise to the cGMP status of the manufacturing unit.
• Experience with refining, developing and implementing manufacturing strategies.
• Previous managerial experience is vital.
• Extensive experience working within cGMP conditions.
• Experience with ATMPs, small molecules or viral vectors.
• Phase 1/2 clinical trials experience.