GMP Production Scientist – Cell Therapy – London
A fantastic opportunity has arisen for a GMP Production Scientist 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. They’ve enjoyed a period of significant growth and it’s a really exciting time to be joining them.
As a GMP Production Scientist you will take a leading rolesin 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
-Degree in a relevent Biological Science discipline.
– 3-5 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.
-ATMP Process development experience.
-Working knowledge of generating process and QC data for regulatory submissions.
In return the company offer fantastic salary and benefits packages. To find out more about this superb opportunity please contact myself, Lauren Gripton, of Paramount Recruitment on firstname.lastname@example.org
Keywords: GMP, manufacturing, good manufacturing practice, BSc, MSc, cell therapy, cell therapies, cellular therapies, ATMP, ATMPS, advanced medicinal therapeutic products.
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
Job Reference: Lg54523_1560422838
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