About Instil Bio
Instil Bio is a cell therapy company developing tumor infiltrating lymphocytes (TIL) for the treatment of solid tumor cancers. TIL are a patient’s own T cells harvested from the patient’s tumor, which are then expanded and reinfused into the patient to target and kill cancer cells. Instil is advancing its proprietary TIL manufacturing expertise, technology, and data into clinical trials, including a planned registrational study with its lead candidate and a first-in-human study of its next-generation engineered TIL. The company is led by world-class cell therapy experts and backed by premier global institutional investors.
Instil Bio UK is Instil’s rapidly-growing, Manchester UK-based subsidiary. Our Manchester subsidiary has significant R&D, process development, and clinical manufacturing capabilities, with approximately 35 staff expanding to > 100 staff. Instil Bio UK has been generating cell therapy products for patient use since 2011, including TIL products and external partner genetically engineered T cell products.
Quality Assurance Specialist (Production & Audits/Qualification)
Instil Bio UK is seeking a highly experienced Quality Assurance Specialist to join the Quality department with an opportunity to be instrumental in the development of clinical and commercial manufacturing capability for the company’s cell-based approach to cancer therapy.
Post holders will provide quality support across the PQS, third party supplier management: production and QC testing activities, training and validation activities.
Key Responsibilities: Including (but not exhaustive)
- Support the Quality Manger in the operation & oversite of the Pharmaceutical Quality Systems including deviation and faults, change control, validation activities, Out of Specification results and self-inspections
- Perform ATIMP batch & QC test reviews
- Maintain a compliant documentation control system including policies, standard operating procedures, batch manufacturing records, validation protocols and quality control reports
- Ensure timely investigation and closure of deviation, faults, audit findings and out of specification results
- Regular review and documentation of CAPAs, ensuring effectiveness of corrective actions
- Support regular QA review meetings
- Provide QA review and guidance to project teams to ensure delivery of GMP compliant manufacturing processes and drug products that are fit for purpose
- Perform vendor qualifications and audits, as well as self-inspections
- Keep abreast of changes to regulations and guidelines, advising the quality team on implications
- Ensure relevant training of staff on QA procedures and regulatory guidelines
- Prepare and lead third party supplier audits
Key Skills, Experience and Behaviours
Qualifications & Experience:
To be successful as our Quality Assurance Specialist it is likely you will be educated to at least BSc level in an appropriate subject area with five or six years (MSc or equivalent with at least four years) of practical experience in pharmaceutical production or Quality Control and quality management. Among which at least one year in quality management, with necessary training relating to the ATMP products being manufactured
- Implementation and management of a GMP Quality System within a manufacturing organisation for sterile biologics medicinal products
- Risk management and application of risk management tools within GMP
- Managing CAPAs and use of KPIs to monitor quality systems
- Review of batch manufacturing records, QC test record and approval in preparation for QP certification
- Excellent understanding of legislation and guidance documents relating to the manufacture of Advanced Therapy Investigational & Medicinal Products
- Leading and performing audits of third parties and overseeing implementation of CAPAs
- Experience working in a regulated environment for example: MHRA, FDA, HTA
Skills & Abilities:
- Excellent verbal and written communication skills
- Ability to influence staff across all functions in order to embrace fundamental quality principles
- Ability to communicate effectively at all levels within the organisation
- Finding pragmatic solutions when dealing with quality incidents or challenges
Remuneration & Benefits
The salary for the Quality Assurance Specialist will be competitive within the Biotechnology and wider Scientific sector with actual salary offered reflecting relevant qualifications and experience as well as performance at interview. In any event we anticipate a salary in the £38,000 to £45,000 range together with an attractive bonus and benefits.
If you would like to join us as Quality Assurance Specialist during this exciting period of growth and you think your skills and experience are a good fit for this role, apply with a current CV and we’ll get back to you within a day or two.