Job title:GMP Production Scientist
Reporting to:Senior GMP Production Scientist
Department:GMP
No of Direct reports:0
Summary:
eXmoor helps clients with the manufacture of cell and gene therapies (CGT) and biopharmaceuticals. We provide; (1) translation consultancy to close the gap between R&D and clinical manufacture, (2) process development services and (3) capital project design through to licensing and (4) GMP manufacturing for early phase clinical trials.
The GMP Production Scientists will support the routine operation of eXmoor’s GMP production suites for a varied range of ATMP clinical products.
This is an exciting opportunity to work with eXmoor’s globally recognised team of scientists, consultants and engineers. You will work on a wide range of Client projects in a rapidly growing business whilst developing your GMP manufacturing career.
Job Purpose:
The GMP manufacturing facility will be capable of handling a wide range of cell and gene therapies as well as small scale complex biologics. The eXmoor facility will comprise of two technical areas Process/Analytical Development & GMP clinical phase production, including a small fill/finish capability and all associated QC, all working closely together such that processes developed in the PD/AD area will be transferred at scale to the GMP suites.
The GMP Production Scientists will carry out day-to-day production activities and routine clean room duties along with supporting the technology transfer of processes from eXmoor’s Process Development Teams.
This is a generic Job Description for GMP Production scientists in the GMP production team, supporting GMP manufacturing in cell culture/fermentation, downstream purification and GMP fill/finish
Main areas of responsibility / key duties:
Production Processes:
* You will assist with the tech transfer & scale-up work within the GMP facility under GMP conditions and provide data for application to the regulatory authorities.
* You will carry out routine duties involved in the GMP manufacture of clinical grade ATMP products including closed processing cell culture, downstream purification and fill/finish at varying scales up to 200L.
* You will work with procurement to ensure GMP approved materials are available and support procurement to ensure delivery of the required materials.
* You will ensure that work in progress and finished products are produced, labelled and stored according to product specification and quality standards.
* You will assist with the development of production methods including closed processing cell culture, downstream purification and fill/finish at varying scales up to 200L.
Production Facility:
* You will assist with the maintenance, operation, cleaning and validation of the Production Equipment in compliance with facility’s stated procedures and standards.
* You will assist with appropriate qualification, process validation and regular re-validations.
* You will assist in the monitoring and control of the production environment and ensure that standards of cleanliness and hygiene are maintained.
Documentation:
* You will support the development and generation of SOPs & Batch Documentation relating to specific GMP facility and specific manufacturing operations.
Safety:
* You will conduct your duties to the highest quality standard and in a safe way complying with all policies and procedures and with due care and attention for yourself and your peers.
* You will comply with GMP and Lab documentation including Risk assessments, SOPs, COSHH forms, lab notebooks and records.
Person Specification:
Essential Qualifications & Experience:
* BSc in Life Science or equivalent experience
* Operating within a GMP Quality system including the management of production deviations, change controls and the principle of quality risk management.
* Understanding or experience of one or more of the following unit operations:mammalian cell culture (adherent &/or suspension, up to 200L scale),autologous and allogeneic C>, purification of vectors, plasmids, whole cells, aseptic filling
* Resilience and flexibility; able to contribute innovatively to solving processing problems.
Desirable Qualifications & Experience:
* Additional work experience in a relevant field
Competences Required:
* Organisation, planning and time management
* Oral and written communication skills
* Teamworking
* Innovation, inquisitiveness, and willingness to learn
* Attention to detail and getting things finished
* Problem solving
* Building constructive relationships and earning respect
* Motivated by growing a bio-technology business in the CGT / biopharmaceutical market
* Proficiency in Office365 (including Word, Excel, PowerPoint).
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