Senior Production Scientist

3 weeks ago

Cambridge, United Kingdom CK GROUP Full time

CK Group are recruiting for a Senior Production Scientist on behalf of a growing Cell Therapy CDMO to be based at their site in Cambridge on a permanent basis.
**About the Company**:
Our client is based in state of the art facilities for multi-product GMP manufacturing, they are currently undergoing an extensive period of growth and development, and are expanding the QA team as part of this growth. They have an established eQMS and LIMSsystem, and their facilities include GMP research lab space and process development suites, GMP manufacturing suites, QC lab space and cryogenic storage.
They are within easy commuting distance from Cambridge City Centre, and with excellent transport links to Central London.
**About the Role**:
The Senior Production Scientist will be responsible for leading, managing and training a team of scientists to support the technology transfer, validation and clinical production of therapeutics for ATMPs within GMP clean rooms.
**Your responsibilities will include**:

- To supervise and lead GMP production (and production staff).
- Lead formulation and banking of cellular therapy products, including cell culture and raw material support.
- Ensure production is in compliance with validated standard operating procedures (SOPs) and regulatory requirements.
- Be accountable for the accurate completion of batch documentation to GMP standards.
- Coordinate activities with the QC department, to ensure efficient sampling and testing of raw materials, in process controls and final drug product.

**About You**:
To be considered for this position you should have the following skills and experience:

- Experience in a Senior Scientist leadership position, including line management and training of staff.
- Experience of working in a GMP Environment (GLP/GCLP/GMP).
- Degree in Biological Science or related Life Science
- Working knowledge of ATMPs and regulations for cell and gene therapy products is desirable.
- Demonstrable knowledge of regulatory compliance including MHRA licensing requirements
- Demonstrable knowledge of Quality Assurance and good documentation practice

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 55114 in all correspondence.

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