GMP Production Team Leader

We are currently looking for a GMP Production Team Leader to join a brand new Cell and Gene Therapy GMP facility in the Bristol area. As the Senior GMP Production Scientist you will be responsible for taking the lead role for establishing GMP Production for a varied range of ATMP clinical products.

This is an exciting opportunity to work on a wide range of client projects in a rapidly growing business whilst developing your GMP manufacturing career.

Your duties as the GMP Production Team Leader will be varied however the key duties and responsibilities are as follows:

1. You will have responsibility for the daily supervision of GMP production activities and teams, whilst playing a leading role in the technology transfer and scale-up work to optimise procedures, providing data for application to regulatory authorities.

2. You will develop different production methods such as closed processing cell culture, downstream purification and fill/finish at varying scales up to 400L.

3. You will lead a manufacturing team whilst carrying out GMP manufacture of clinical grade ATMP products. Additionally you will maintaining, validating, and controlling the production process and environment.

4. By supporting procurement, you will be ensure GMP materials are specified and minimise the risk of impact on the production schedules and project timelines.

To be successful in your application to this exciting opportunity as the GMP Production Team Leader we are looking to identify the following on your profile and past history:

1. Relevant BSc, or MSc degree in a Life Science / Engineering discipline.

2. Proven industry experience working in GMP clean room facilities in a supervisory role, manufacturing ATMP or biological productions for human use.

3. A working knowledge and practical experience with writing SOPs, Risk Assessments, Material Risk Assessments, equipment and process qualification, as well as procurement to GMP principles.

Key Words: GMP | ATMP | Cell Therapy | Clean Room | Quality Contorl | QC | Validation | GLP | MHRA | Cell Culture | Biopharmaceutical | Pharmaceutical | SOP | Engineering | Life Science | Manufacturing | COSHH | Supervisor | Senior Scientist | Risk Assessment | Material Risk Assessment | Downstream | Downstream Purification | Production Technician | Gene Therapy | Analytical Development | Tech Transfer | Product Development