QA Manager Cell TherapeuticsBased in London and HertfordshirePaying £55,000 £70,000 + Excellent Benefits Do you have significant experience of QA Activities from within a GMP...
Senior GMP Manufacturing Associate (Cell Therapeutics)
Based in Hertfordshire
Competitive Salary + Package
Do you have experience within GMP Cell Manufacturing?
Would you like to work in a diverse role for a leading Cell Therapy company?
My client is establishing a new Manufacturing Operations group that is responsible for the technology transfer and manufacturing of its pioneering immunotherapy products.
They are seeking a Senior GMP Manufacturing Operator with experience of executing cell and gene therapy manufacturing processes in an aseptic cleanroom environment. In addition to the manufacturing operations, the associate will be supporting process development activities, design and optimisation of the manufacturing process and technology transfer.
This role provides a unique opportunity to be involved with the set-up and execution of a new manufacturing operation as well as supporting process development and manufacturing scale activities.
We are looking for someone who thrives in a pioneering environment where a new science and new models for manufacturing are being developed.
- Performing all tasks associated with the manufacture and QC testing of Advanced Therapy Investigational Medicinal Products including execution of the process, cleaning and environmental monitoring
- Leading/supporting day-to-day manufacturing operations including: Equipment maintenance & calibration, stock management and supply chain
- Generating batch records for the manufacture and testing of novel immunotherapy products
- Leading/supporting the set-up of the manufacturing facility and licencing including; writing and reviewing of SOPs, validation and EHS documentation
- Mentoring junior manufacturing associates
- Leading/supporting the technology transfer of immunotherapy products into the manufacturing facility
- Supporting the design of robust, scalable, cost effective, manufacturing processes for novel immunotherapies
- Developing improved manufacturing processes to increase yield, reduce process variability and ensure process scalability and cost effectiveness for later phase trials and commercialisation
To be considered you'll need the following skills and experience;
- Bachelor's, Masters or PhD degree in science, biology, cell biology engineering or relevant equivalent
- Minimum of 3 years experience in performing aseptic manufacturing processes in a GMP cleanroom environment.
- Experience in performing cell therapy processes including cell culture, media preparation, aseptic filling and cryopreservation is essential.
- Experience of performing QC assays for in process controls and final product testing. Experience with flow cytometry , microscopic and cell base assays is highly beneficial
- Demonstrated experience of executing manufacturing processes with strict adherence to SOPs under GMP regulations and completion of manufacturing batch records to meet Quality requirements
- Experience of generation and review of GxP documents including equipment validation, batch records, change controls, deviations and CAPAs
- Excellent Communication skills (written & verbal) are essential, as is a good level of self-motivation and the ability to motivate others.
- Experience of setting-up a new GMP manufacturing facility, manufacture of T-Cells and viral vectors, supply chain, cold chain logistics, fill/finish and cryopreservation or supporting regulatory submissions would be an advantage.
"Cell Culture, Mammalian cell culture, Immunology, cell biology, immunotherapeutics, T-Cell, clean room, GMP, GCP, fermentation, ATMP, Advanced Therapeutic Medicinal Product, production, manufacturing, cellular therapeutics, flow cytometry, immune"
Please apply online, or call Neil Walton on 02030964706