Our Client has embarked on cGMP manufacturing operation in the UK, in Greater London Location.
The Senior Director of Manufacturing will report to the VP of Manufacturing and will be responsible for clinical planning, production and QC activities.
The candidate will be expected to grow and manage the manufacturing teams as we scale-up and build manufacturing capacity at the UK site. This position offers an exciting opportunity to join the team at an early stage, to deliver life saving therapies.
- Provide strategic guidance and leadership to the Planning, Production and QC teams for GMP manufacturing operations
- Execute strategic planning processes to process and test clinical batches to meet clinical schedules
- Provide technical direction, oversight and support to Production and QC teams for clinical manufacturing
- Build scaleable manufacturing processes and teams to ensure future capacity is available to meet medium and long term clinical forecasts
- Author and review UK related CMC content for IND submissions for clinical trials
- Deliver technology transfer strategy for new product introduction programs, working with the Process Development team and key CMOs
- Build out the MSAT laboratory to implement local improvement programs to reduce manufacturing lead times and improve costs and productivity
- Partner with US Process Development teams to deliver process robustness improvement and capacity build for production and analytics programs
- Integrate clinical planning processes with production and QC using appoved clinical tracking software tools
- Team with QA to ensure all supply chain, production and QC processes are compliant to all MHRA and HTA requirements
- Monitor performance with key performance indicators, KPIs, for production and quality control processes
Qualifications and Experience:
- A Ph.D in a Biological or related science
- A minimum of 10 years progressive manufacturing experience in an industrial or clinical setting with at least 5 years in the ATMP sector
- Working knowledge and ability to apply GMPs in conformance with FDA, MHRA, EU and ICH standards for supply chain and logistics operations
- Experience in cleanroom operations and aseptic processing operations
- Experience in regulatory inspections from MHRA or other regulatory bodies
- Ability to scale-up manufacturing operations and build effective leaders and teams
- Good interpersonal, verbal and written communication skills
- Comfortable in a fast-paced small company environment with minimal direction