The GMP manufacturing facility is capable of handling a wide range of cell and gene therapies as well as small scale complex biologics. The eXmoor facility comprises of two technical areas (Process/Analytical Development & GMP clinical phase production, including a small fill/finish capability and all associated QC), both working closely together such that processes developed in the PD/AD area will be transferred at scale to the GMP suites.
The Senior GMP Production Scientists will take responsibility for the day-to-day supervision of GMP production teams and production activities along with playing a lead role in the technology transfer of processes from eXmoor’s Process Development Team and clients.
This is a generic Job Description for Senior GMP Production scientists in our GMP production team, leading GMP manufacturing in cell culture/fermentation or downstream purification and supporting GMP fill/finish.
Main areas of responsibility / key duties:
Production Processes:
- You will support the tech transfer & scale-up work within the GMP facility to optimise the procedure under GMP conditions and provide data for application to the regulatory authorities.
- You will be responsible for the supervision of a number of Production Scientists & carry out GMP manufacture of clinical grade ATMP products in accordance with GMP & the Product Specification File.
- You will ensure GMP materials are specified and minimise the risk of any impact on the production schedules and project timelines by supporting procurement.
- You will ensure that work in progress and finished products are produced, labelled and stored according to product specification and quality standards.
- You will develop production methods including closed processing cell culture, downstream purification and fill/finish at varying scales up to 400L.
Production Facility:
- Working with the maintenance team you will ensure that the maintenance, operation, cleaning and validation of the Production Equipment are completed in compliance with facility’s stated procedures and standards.
- You will ensure that the appropriate qualification, process validation and regular re-validations are completed successfully and on schedule.
- You will assist in the monitoring and control of the production environment and ensure that standards of cleanliness and hygiene are maintained.
Training:
- You will work as a team to develop and deliver the required initial and continuing training of production & support personnel for production operations, ensuring training is maintained and adapted as required.
- You will take responsibility for coaching and mentoring more junior Scientists.
Documentation:
- You will develop and generate SOPs & Batch Documentation relating to specific GMP facility and manufacturing operations.
- You will play a leading role in generating & reviewing data and for the application to the regulatory authorities for Clinical Trial Authorisation.
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.
Projects:
- You will present data to our clients and take part in the technical discussion during project team meetings.
- You will support project management with any scope changes when required.
Person Specification:
Essential Qualifications & Experience:
- MSc in Life Science / Engineering degree or BSc with relevant years industry experience.
- Considerable experience (3 years plus) of working in GMP clean room facilities, manufacturing ATMP or biological productions for human use.
- Experience in equipment and process qualification.
- Experience with generation of materials risk assessments, materials specifications and procurement to GMP principles.
- Understanding of regulatory & licensing requirements for MHRA in Good Manufacturing Practice as applied to small scale biopharmaceutical production for clinical trials
- Operating within a GMP Quality system including the management of production deviations, change controls and the principle of quality risk management.
- Experience in a supervisory role. This includes the ability to, develop, motivate, and organise a small team.
- Experience of managing production schedules and ensuring the implementation of operating procedures and efficient record keeping.
- In depth understanding and experience of one or more of the following unit operations
- mammalian cell culture (adherent &/or suspension, up to 400L scale)
- autologous and allogeneic C>
- purification of vectors, plasmids, whole cells,
- aseptic filling
- multi-product facilities
- understanding GMP
- Resilience and flexibility; able to contribute innovatively to solving processing problems.
- Previous experience with Technology Transfer from Process Development to GMP environments.
Desirable Qualifications & Experience:
- Knowledge of Good Laboratory Practice (GLP) and routine in-process and QC assay techniques for ATMPs.
- Preparation for audits with FDA/MHRA and other regulatory bodies.
Competences Required:
- Organisation, planning and time management
- Oral and written communication skills
- Leadership and 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).
