Senior GMP Manufacturing Associate (Cell Therapeutics)Based in HertfordshireCompetitive Salary + Package Do you have experience within GMP Cell Manufacturing?Would you like to work in a...
GMP Manufacturing Operations Manager (Cellular Therapeutics)
Based in Hertfordshire
Competitive Salary + Excellent Benefits
Do you have experience within the GMP production of Cellular Therapeutics or Sterile ATMPs?
Would you like to work for a pioneering Cellular Therapeutics Organisation?
My client are a clinical stage Biotech with a promising pipeline of clinical stage cellular therapeutics. Following the expansion of their business they are looking to hire a full time GMP Manufacturing Operations Manager to take a lead role in the set up and running of a new Manufacturing Operations group that is responsible for the technology transfer and manufacturing of its pioneering immunotherapy products.
We are seeking an ambitious, highly motivated, experienced GMP Operations Manager to develop the Manufacturing Operations team and lead the set-up of the new Manufacturing Operation for delivery of the first clinical material in 2019.Key Responsibilities will include;
- Leading the set-up of the operation of a new cell and gene therapy facility to ensure that it is ready to manufacture products for clinical trials by end 2019.
- Managing the manufacturing operations team including, identification of resource needs, ensuring all direct reports have appropriate training to be able to execute their role, professional development of direct reports.
- Establishing and optimising the technology transfer process and leading the right first time transfer of the products into the facility.
- Supporting the quality and validation groups through writing, reviewing and approving documents including change controls, deviations, CAPA to ensure compliant and efficient manufacturing operations.
- Supporting the VP Manufacturing Operations with the development of a high performing operations team and the manufacturing strategy for the business
- Supporting other activities as required for start-up and operation of the manufacturing facility and to other meet business needs.
To be considered for the role you will need the demonstrate the following skills and experience;
- Substantial experience working in a GMP environment with experience in a GMP Operations leadership role.
- Hands-on experience executing small-scale aseptic/sterile manufacturing processes for clinical trials
- Experience of generation and review of GxP documents to ensure running of a compliant manufacturing process and operation
- A good working knowledge of EU GMP, cleanrooms, aseptic technique and hygienic requirements for sterile products
- Able to work well under pressure when handling multiple activities under short timeframes
- Excellent interpersonal and communication skills (written and verbal)
- Highly self-motivated and able to motivate others
- Able to work well with ambiguity, solution orientated and a hands-on approach.
- Experience of setting-up a new GMP manufacturing facility
- Experience with technology transfer of cell-based therapies and analytical methods
- IOSH or NEBOSH qualified
Key Words "Cell Culture, T-Cell, Cellular Therapeutics, Immunology, Sterile, Aseptic, GMP, Stem Cell, Cleanroom, Clean Room, Manager, Production Manager, Manufacturing Manager, Immunotherapy, Immuno oncology, Operations Manager"
Please apply online or call Neil Walton on 0203 096 4706
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.