Principal Production Scientist
Achilles Therapeutics
- Stevenage, Hertfordshire
- Permanent
- Full-time
- Coordinate day-to-day manufacturing activities, including oversee operational scheduling.
- Provide a high level technical expertise on GMP production knowledge.
- Lead preparation of GMP compliant documentation including but not limited to change controls, SOPs, URS, Risk Assessments, Qualification and validation, deviations and CAPAs.
- Review batch manufacturing documentation and records.
- Support the development and clinical manufacture of ATIMPS.
- Ensure operational excellence and exercise good house keeping
- Lead GMP activities for the clinical manufacture of ATMPs, manage the team of GMP operators to ensure delivery of clinical batches,
- Perform ATMP manufacturing for clinical trials and ensure all manufacturing activities are undertaken in accordance with production requirements and GMP regulatory and quality standards in close collaboration with QA, QC, TS and MSAT department.
- Support intermediate and final drug product manufacture.
- Lead the cross-functional collaboration to coordinate patient sample procurement, labelling, packaging and distribution of starting materials and final DP delivery,
- Support Head of Production in scheduling all clean room activities including manufacturing slots, personnel and equipment.
- Review batch manufacturing documentation and records, including BMRs, and intermediate reagents and product to ensure are released and available for use.
- Support continued improvement activities to streamline process operations and optimisation of manufacturing methods.
- Lead the preparation and review of GMP documentation including BMRs, SOPs, Change Control, process deviations, and risk assessments to ensure the highest levels of controls and traceability.
- Coordinate activities with QC to ensure appropriate and timely sampling and testing of in-process samples and finished product.
- Coordinate the maintenance of a laboratory environment suitable for the manufacture of ATMPs, work closely with operations team to support equipment validation and qualification, and materials management.
- Work with external service providers.
- Facilitate technology transfer, and process validation of new generation processes.
- Provide support and supervision for junior GMP production scientists.
- BSC/MSC in a Biological Science discipline.
- Excellent demonstrable experience working in a regulated environment (GLP/GCLP/GMP).
- Experience in human cell isolation, and cell and tissue culture in a GMP compliant environment.
- Experience on Batch Reviews.
- Ability to work in a Grade C/A cleanroom production environment.
- Ideally, previous experience working with Grade A Isolator.
- ATMP Process validation experience.
- Understanding of GMP, ATMP, and EUTCD regulations.
- Working knowledge interpretation of and QC data.
- Strongly focused on quality and safety.
- Have excellent planning and organisational and time management skills.
- Previous experience on operational schedule.
- Good communicator with an ability to influence at every level.
- Must have an understanding of Cell and Gene Therapy.