OVERALL ROLE OBJECTIVE
The Quality Control (QC) Microbiology Scientist will work with and support the Production, Product Development, and Clinical teams to ensure operational excellence and to exercise good housekeeping, high standards of cleanliness and compliance to GMP procedures in all areas. Experience in, environmental monitoring and microbial Identification is essential. Sterility testing (BACT), qPCR mycoplasma testing, bioburden and endotoxin testing, would be beneficial.
The post holder 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 Senior 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:
- Providing specialist microbiological knowledge, practical expertise, problem solving/troubleshooting skills and good time management ability.
- Environmental monitoring of a clean room facility and microbial identification using gram stain, catalyse and oxidase tests and Vitek methodology.
- Performing cleanroom validation including generation of protocols and reports.
- Proficiency in performing endotoxin and qPCR mycoplasma testing, BACT sterility testing.
- Analysis of samples (raw materials, products and environmental) in full compliance with the controlled methods and procedures.
- Assisting in the control, receipt and release of raw materials, and final products to GMP requirements.
- Where appropriate, analysing and evaluating QC methods, techniques, processes and machinery 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 and microbiological 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 and microbiological expertise.
- Reporting, to the line manager/supervisor, 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, change controls, study protocols, TSE evaluations, COSHH/BIOCOSHH assessments and Risk Assessments.
- Assisting the line manager/supervisor in analytical and microbiological laboratory management activities including, but not limited to equipment planning/procurement, ordering of reagents and consumables, maintaining calibration and servicing records, ensuring equipment compliance and ensuring a clean, organised and smooth-running working environment.
QUALIFICATIONS
- Degree level education in a sciences discipline.
SKILLS & EXPERIENCE
- Experience in microbiology techniques such as microbial identification.
- Experience in environmental monitoring of GMP cleanrooms.
- Excellent attention to detail with a desire to continually develop and improve our processes.
- The ability to work effectively within a small team.
- A determination to succeed.
- The ability to work under pressure.
- Flexibility and enthusiasm.
- Ability to work to deadlines and deliver results.
- Excellent written/oral communication and interpersonal skills
- Excellent Microsoft Office skills
- Thorough approach and high attention to detail
- Strong time management and organisational skills
- Knowledge and understanding of an aseptic manufacturing environment to Annex 1
- Experience of electronic QMS /Documentation system
- The ability to work effectively with limited supervision
- Cleaning validation experience
- Understanding of Process simulations tests for process and operator qualifications
- At least 5 years’ experience within an aseptic GMP manufacturing facility
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. As we continue to expand, there will be career opportunities on a truly global scale.
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 which includes a Holiday Allowance of 32 days, pension, and free car parking.
Lab-based
Hours: 37.5 per week Monday to Friday, normal office hours apply