About Instil Bio
The transition from the era of pharmaceuticals to the era of biotechnology brought tremendous medical innovation to patients’ lives. Come join us as we lead the next transition – from biotechnology to cell therapy.
Instil Bio is a rapidly growing and dynamic cell therapy company; we are building the team that will establish cell therapy as the third pillar of therapeutic medicines. Our people work in a highly collaborative, fast-paced environment, marrying our expertise and dedication with our desire to help patients in need. We offer attractive and competitive compensation plans and benefit programs.
Senior/Quality Assurance Specialist (Manufacturing & Audits/Qualification)
We now have one remaining opportunity in our Quality Assurance team at Specialist or Senior Specialist level. Our Quality Assurance Specialists provide quality support across the Pharmaceutical Quality System: third party supplier management; production and QC testing activities; training and validation activities.
We are looking for someone to focus on the production and/or validation aspects of Quality Assurance. This is a senior role in which you will be instrumental in the development of clinical and commercial manufacturing capability for the company's cell-based approach to cancer therapy.
Key Responsibilities Including (but not exhaustive):
You will support the Quality Manager 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 reviews
* Work with 3rd party validation specialists to ensure execution of equipment and process validation activities
* 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
Relevant Education Skills and Experience
In order to be successful in the role of Senior / Quality Assurance Specialist it is envisaged that you will possess the following qualifications, skills and experiences:
* Educated to at least BSc level in an appropriate subject area - preferably life sciences
* Several years of practical experience in sterile pharmaceutical production or some other operational function regulated by MHRA and FDA (HTA a bonus)
* 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, process and equipment validation protocols
* Leading and performing audits of third parties and overseeing implementation of CAPAs
* 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
Whilst not essential it may be an advantage if you have experience of:
* Legislation and guidance documents relating to the manufacture of Advanced Therapy Investigational & Medicinal Products
* Implementation and management of a GMP Quality System within a manufacturing organisation for sterile biologics medicinal products
* Cell therapy, personalised medicines or biologics manufacture
Remuneration & Benefits
The salary for the Senior / 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 £37,000 to £55,000 range together with an attractive bonus and benefits.
There is opportunity to work a shift pattern for which an additional shift allowance will be paid.
If you would like to join us as Senior / 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
Product Quality Assurance