Job description
OVERALL ROLE OBJECTIVE
The post-holder will be expected to support in-process/batch release testing and validation activities within the QC department and across other departments including GMP Production (cell therapy manufacture) and Product Development (technology transfer and product characterisation). This role will be integral in bridging the processes between the Product Development and QC departments by validating assays/processes to GMP standards. The QC Cell Biology Scientist will ensure operational excellence through exercising good housekeeping, high standards of cleanliness and compliance to GMP procedures in all areas.
The QC Cell Biology Scientist will join TC BioPharm Ltd (TCB), an established cancer 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 QC Supervisor. TCB is a fast growing, immunotherapy company developing cell-based treatments for cancer patients; moreover, our unique culture, values and working environment attracts, retains, and inspires people to give their best.
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
· Performing Peripheral Blood Mononuclear Cell (PBMC) isolation and cell culture expansion.
· Maintenance of mammalian cell lines to include passaging and cryopreservation.
· Performing QC in-process/release testing of intermediate and dug products.
· Optimisation and/or validation of flow-cytometry based assays, qPCR and ELISA.
- Preparing and writing validation protocols and reports, standard operating procedures and specifications to quality and regulatory standards.
- Ensuring work is performed in accordance with the Company’s QA and Health and Safety policies including the provision of COSHH/BIOCOSHH/Risk assessments
- Training both experienced and inexperienced members of staff.
- Reporting to the line manager/supervisor any Quality Events occurring during the manufacturing or quality control process and ensuring a report is submitted and corrective and preventative actions progressed to completion.
- Assisting the line manager/supervisor in laboratory management activities including, but not limited to, cleaning and housekeeping, ordering of reagents and consumables, maintaining calibration and servicing records, ensuring equipment compliance and ensuring a clean, organised and smooth-running working environment.
- Participating in the on-call equipment rota for monitoring of critical equipment at TC BioPharm’s GMP facility.
QUALIFICATIONS
· Degree level education in a biological science discipline.
SKILLS & EXPERIENCE
· Experienced in mammalian cell culture techniques is essential.
· Practical flow cytometry and ELISA experience is essential.
· QPCR experience is desirable.
· Experience of working in a GMP environment is essential.
· Technical experience in validating assays is essential.
· A high level of attention to detail with a desire to continually develop and improve processes.
· A passion for science.
· The ability to work under pressure.
· Ability to work to deadlines, demonstrating flexibility and delivering results.
· Assay validation/optimisation experience will be viewed favourably
- 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. This is an opportunity to be part of a growing, ambitious business where people development is critical to future success.
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 (occasional ad hoc irregular working hours may be required)
Laboratory-based role
Job Types: Full-time, Permanent
Benefits:
- Company pension
- Life insurance
- On-site parking
- Private medical insurance
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Motherwell, North Lanarkshire: reliably commute or plan to relocate before starting work (required)
Education:
- Bachelor's (preferred)
Work Location: In person