Head of GMP Production - ATMP
An established biotechnology company is advertising a vacancy for a Head of GMP Production - ATMP position based in London. The company develops next-generation, patient-specific therapeutics that allow scientists to combat cancer without harming healthy tissues. This is an exciting opportunity to work with a dynamic and revolutionary organisation.
- Lead GMP activity for the manufacture of the company's advanced therapy platform and 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.
- 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.
- Lead operations for 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.
- Ensure maintenance of GMP cleanroom environment suitable for the manufacture of ATMPs
- Work with external service providers.
- Provide support, leadership, and supervision for GMP production scientists.
Skills and Requirements:
- BSC/MSC in a Biological Science discipline.
- 10 years' experience in a scientific laboratory role.
- 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.
- ATMP Process validation experience.
- Understanding of GMP, ATMP, and EUTCD regulations.
- Working knowledge of generating process and QC data for regulatory submissions.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Charlotte Allen at +44 203 854 2621 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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