OVERALL ROLE OBJECTIVE
The post holder will be responsible for analysis of raw materials and products to GMP standards and perform cell-based assays and flow cytometry assays to a high standard. In addition, the QC Analytical Scientist will contribute to the effective technology transfer and validation of assays from TC BioPharm’s Process Development department into the Quality Control department.
The QC Analytical Scientist will work with and support the Quality Control, Quality Assurance, Facilities, Production and Process Development teams to ensure operational excellence in the manufacture and testing of TC BioPharm’s products. They will exercise good housekeeping, high standards of cleanliness and compliance to GMP procedures in all areas.
The QC Analytical Scientist will join TC BioPharm Ltd (TCB), an emerging 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 Quality Control Analytical Supervisor. TCB is a fast growing, immunotherapy company; moreover, our unique culture, values and working environment attracts, retains, and inspires people to give their best.
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Providing specialist knowledge into Flow cytometry and Cell Culture, including practical experience, problem solving/troubleshooting skills and good time management ability
- Carry out cell-based assays and cell culture to GMP standards. Including performing isolation and expansion of PBMCs.
- Verification and validation of assays.
- Analysis of intermediate and final products in full compliance with the controlled methods and procedures, to GMP requirements.
- Assisting in the control, receipt and release of raw materials.
- Where appropriate, analysing and evaluating methods, techniques, processes and equipment to develop and implement improvements or changes, in order to maintain the highest levels of performance within the department.
- Ensuring work is performed in accordance with the Company’s QA and Health and Safety policies including the provision of COSHH/BIOCOSHH/Risk assessments.
- Ensuring that analytical equipment is calibrated and maintained in accordance with GMP quality systems. Be able to identify deviations and faults in instrument performance and determine an appropriate response to them.
- Training and supervising both experienced and inexperienced members of staff so that technical knowledge and competence is communicated effectively. Where applicable, correct and coach colleagues to ensure continuance of a high level of analytical expertise.
- Reporting, to the line manager, any deviations occurring during the manufacturing or quality control process and ensure a deviation report is submitted and corrective and preventative actions progressed to completion.
- Preparing and maintaining documentation to appropriate quality standards, including, but not limited to, laboratory notebooks, standard operating procedures, study protocols and reports, TSE evaluations, COSHH/BIOCOSHH assessments and Risk Assessments.
QUALIFICATIONS
- Degree level education in a biological science discipline.
- At least 3 years relevant experience.
SKILLS & EXPERIENCE
- Experience in cell culture techniques is essential.
- Experience in GMP test methods is essential (or equivalent).
- Experience in flow cytometry techniques is essential.
- Excellent attention to detail with a desire to continually develop and improve processes.
- The ability to work effectively within a small team.
- A determination to succeed.
- Flexibility and enthusiasm.
- Ability to prioritise work to meet clinical and commercial deadlines.
- Experience in performing and reporting investigations using root cause analysis techniques is desirable.
- Excellent written/oral communication and interpersonal skills.
- Excellent Microsoft Office skills
- Thorough approach and high attention to detail.
- Strong time management and organisational skills.
Lab based