Head of GMP Production- Cell Therapy- Hertfordshire
A fantastic opportunity has arisen for a Head of GMP Production to join an expanding and truly cutting edge company based in Hertfordshire. As an organisation their science is ground-breaking and they are looking for the next phase of talented scientists to further build on their highly successful growth phase.
As the Head of GMP Production you will support the technology transfer, validation and clinical production of advanced therapies and also working closely with the product development team to support process engineering activities.
*Leading GMP activity for the manufacture of advanced therapies and facilitate technology transfer, process validation, equipment validation and qualification, stability studies and materials management.
*Provide support, leadership and supervision for GMP production scientists
*Support process engineering activity and continued development activity to streamline process operations and optimisation of manufacturing methods
*To assist/lead in the preparation and review of GMP documentation
*Lead operations for ATMP manufacturing for clinical trials and ensure all manufacturing activities are undertaken in accordance with production requirements and GMP standards.
*To coordinate activities with QC to ensure appropriate sampling and testing of raw materials, in-process samples and finished product.
*Ensure maintenance of GMP cleanroom environment suitable for the manufacture of ATMPs
*Work with external service providers
-BSC/MSC/Phd in a Biological Science discipline.
-10 years’ experience in a scientific laboratory role and a minimum of 5 years’ experience working in a regulated environment (GLP/GCLP/GMP).
-Experience in human cell isolation, and cell and tissue culture in a GMP compliant environment.
-Able to work in a Grade B cleanroom production environment.
-Understanding of GMP, ATMP, and EUTCD regulations
-Strongly focused on quality and safety.
This is a unique opportunity to join a company in an exciting start-up phase and to lead a new core team who will play a vital role in scale-up and expansion of manufacturing. In return the company are offering a fantastic package including share options and bonus. There is also plenty of opportunity for career development and growth. To find out more about this superb opportunity please contact myself, Lauren Gripton, of Paramount Recruitment on firstname.lastname@example.org
Keywords- atmp, atmps, gene therapy, cell therapy, cell therapies, cellular therapies, gmp, good manufacturing practice, production, manufacturing, manager.
Job Reference: Lg5243_1573827495
Broadcast As: 196
Salary To: Negotiable
Job Type: Full Time
Job Term: Permanent
Job Industry: Biotech
Job Specialism: Science R and D
Recruitment Consultant: Lauren Gripton