GMP Production Scientist/Senior Production Scientist – Cell Therapy – London
A fantastic opportunity has arisen for GMP Production experts from Scientist to Senior Scientist level to join an expanding clinical stage biotechnology company in London. As an organisation they are committed to developing next generation, patient specific therapies, bringing together strong expertise across cancer evolution, bioinformatics and cellular therapy.
As GMP Production Scientists you will take leading roles in the development of next generation medicines. You will support the technology transfer, validation and clinical production therapeutics ATMP pipelines within GMP clean rooms and work closely with the product development team to support process engineering activities.
Supporting GMP activity for the manufacture of ATMPs to facilitate technology transfer, process validation, equipment validation and qualification, stability studies and materials management.
Support process engineering activity in closed system cell culture and identifying and implementing procedures in accordance with GMP and regulatory standards.
Support continued development and in-process improvement activity to streamline process operations and optimisation of manufacturing methods
To assist/lead in the preparation and review of GMP documentation including BMRs, SOPs, Change Control, user requirement specifications, process deviations, and risk assessments to ensure the highest levels of controls and traceability
Perform ATMP manufacturing for clinical trials and ensure all manufacturing activities are undertaken in accordance with production requirements and GMP regulatory and quality standards.
Assist/lead in coordination of production scheduling activity, labelling, packaging and distribution of starting materials, raw materials and final drug product
To coordinate activities with QC to ensure appropriate and timely sampling and testing of raw materials, in-process samples and finished product.
Assist/lead in the maintenance of a laboratory environment suitable for the manufacture of ATMPs
Be accountable to the head of production for all production operations
-MSC in a Biological Science discipline.
-5 years’ experience in a scientific laboratory role.
-3 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.
-ATMP Process development experience.
-Working knowledge of generating process and QC data for regulatory submissions.
To find out more about this superb opportunity please contact myself, Lauren Gripton, of Paramount Recruitment on email@example.com
Keywords: GMP, manufacturing, good manufacturing practice, BSc, MSc, cell therapy, cell therapies, cellular therapies, ATMP, ATMPS, advanced medicinal therapeutic products.
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Job Reference: Lg54354_1545210024
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