Senior GMP Production Scientist
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Hobson Prior are looking for a Senior GMP Production Scientist to join a biopharmaceutical company, that is focused on developing specific therapies that harness the immune system to destroy cancer cells. This role will be on a permanent basis and will be located in Stevenage.
- You will perform ATMP manufacturing for clinical trials and confirm all manufacturing activities are undertaken in accordance with production requirements and GMP regulatory and quality standards.
- You will support GMP activity for the manufacture of ATMPs to facilitate technology transfer, process validation, equipment validation and qualification, stability studies and materials management.
- To support process engineering activity in closed system cell culture and implementing procedures in accordance with GMP and regulatory standards.
- To 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.
- To coordinate activities with QC to ensure appropriate and timely sampling and testing of raw materials, in-process samples and finished product.
- Assist in the maintenance of a laboratory environment suitable for the manufacture of ATMPs.
- You will be working with external service providers.
- Be accountable to the head of production for all production operation.
- Provide support and supervision for junior GMP production scientists.
- Assist/lead in coordination of production scheduling activity, labelling, packaging and distribution of starting materials, raw materials and final drug product
- Support continued development and in-process improvement activity to streamline process operations and optimisation of manufacturing methods.
- Strongly focused on quality and safety.
- Have excellent planning and organisational and time management skills.
- Have good communication and interpersonal skills
- Self-motivated with strong initiative and drive.
- BSC/MSC in a Biological Science discipline.
- At least 5 years' experience in a scientific laboratory role.
- Minimum of 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.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
$130000 - $140000 per annum
A fantastic opportunity has arisen for a driven Scientist II - Upstream Process Development to execute and further improve the organisation's cell culture platform.