OVERALL ROLE OBJECTIVE
The post holder will be responsible for ensuring the manufacture of products to GMP standards and assist in the effective technology transfer of projects from the Product Development team to GMP Production. A key aspect of the position will be to perform primary cell culture (including isolation, expansion and formulation) and to strictly adhere to procedures with the accurate completion of documentation to ensure GMP compliance. The post-holder will also work with and support activities across all other departments including the Quality and Clinical teams to ensure operational excellence and to exercise overall responsibility for good housekeeping, high standards of cleanliness and compliance to GMP procedures in all areas.
The Production Scientist will join TC BioPharm Ltd (TCB), an established immunotherapy company developing cell-based treatments for cancer and severe viral infections. Based at their manufacturing facility in the central belt of Scotland, the successful candidate will report directly to the Production Supervisor. The successful candidate will form an integral part of the Production team, which is responsible for the GMP manufacture of TCB’s portfolio of γδ T cell-based therapies and products for clinical use. This is an exciting time to join the company to help support TCB’s COVID-19 and AML clinical trials.
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Perform under a verifier and operator capacity to manufacture TCB’s portfolio of γδ T cell-based therapies for clinical use. This involves cell culture (including isolation, expansion and formulation) to GMP standards.
- This will involve the individual being able to gown appropriately into a Cleanroom Environment (Grades D to A).
- Perform successful process simulation tests for operator and process qualifications.
- Ensure all manufacturing activities are undertaken in accordance with the registered product requirements and to current regulatory and quality standards.
- Analyse all production methods, techniques, processes and machinery and develop and implement improvements or changes in order to maintain the highest levels of performance within the department.
- Perform problem solving trouble shooting of cell culture production processes by identifying issues and implementing procedures in accordance with GMP and relevant regulatory standards and in accordance with TC BioPharm Quality Systems.
- Provide a high level of specialist technical and GMP production knowledge to deliver the technical transfer and validation of mammalian cell culture processes. Be fully trained in both the process technologies and key process parameters relevant to all new products.
- Analyse, interpret and report production data and deviations to line manager, quality and project team. Present results in GMP compliant documentation; including at meetings to update project team or senior management.
- Champion high standards in production documentation ensuring that all procedures are documented and reviewed to appropriate quality standards.
- Assist in production activities including but not limited to; performing EM (viable and non-viable), cleaning and housekeeping, cleaning and transfer of consumables, CAPEX equipment planning/procurement, ordering of reagents and consumables, maintaining calibration and servicing records, training records updated accordingly, ensuring equipment compliance and a clean, organised production environment.
- Ensure quality standards are maintained in compliance with GMP standards and that work is performed in accordance with TC BioPharm’s QA and Health and Safety policies including the provision of COSHH/Risk assessments.
- Assist in the preparation and review of GMP compliant documentation for the GMP Facility including, but not limited to, Batch Manufacturing Records, Standard Operating Procedures, Technical transfer documentation, Plans & Reports, Change Control, Deviations, COSHH assessments and Risk assessments.
- Report to the line Manager, any deviations occurring during the manufacturing process and ensure a deviation report is submitted and corrective and preventative actions progressed to completion.
QUALIFICATIONS
- A degree or higher education qualification in a relevant life sciences discipline.
SKILLS & EXPERIENCE
- Experience working within a GMP cleanroom environment.
- Experience in cell culture and aseptic techniques is preferred.
- Experience in updating and creating relevant GMP documentation would be advantageous.
- Excellent written/oral communication and interpersonal skills.
- Excellent Microsoft Office skills.
- Thorough approach and high attention to detail.
- Strong time management and organisational skills.
If you are looking to work within a challenging, dynamic, and rewarding environment, then TCB represents an excellent career move.
TCB is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment.
Full-time, permanent role, working 37.5 hours per week Monday to Friday.
Office/Laboratory based.