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.
Senior QA Associate
We are now recruiting a Senior QA Associate to join the Quality team at our Manchester site. You will assist in the development of the different functions and commercial manufacturing capability for the company’s cell-based approach to cancer therapy.
You will provide quality support for each function (Manufacturing, QC and Qualification), gathering data and ensuring that PQS Key Performance Indicators are maintained to ensure Instil Bio UK meets its quality objectives.
This is a great opportunity for someone working in Production, QC or another operational function to transition into a QA role in the growing Cell Therapy sector.
Key Responsibilities Include (but not limited to):
- Gather data which is generated from the operational function (Manufacturing, QC and Qualification) to be reported in QA meetings and for Key Performance Indicator tracking.
- Support the Quality Specialist in performing review of: Batch Manufacturing Records, Quality Control data or Qualification and/or Validation activities as required.
- Assist in maintaining a compliant documentation control system including policies, standard operating procedures, batch manufacturing records, validation and/or qualification protocols and quality control reports.
- Provide support to the Quality Specialist to enable to closure of deviation faults, audit findings and out of specification results to timelines.
- Assist in any CAPA implementations required to perform PQS process improvements.
- Perform Archival of quality and Batch related documents according to standard operating procedures.
Relevant Education Skills and Experience
In order to be successful in the role of Senior QA Associate it is envisaged that you will possess the following qualifications, skills and experiences:
- Education to degree level in appropriate subject area – BSc or equivalent.
- At least two years of practical experience in pharmaceutical / ATMP in one of the following: Production, Quality Control, Qualification, Document Control of PQS system.
- Knowledge of PQS tenants such as: Deviations, CAPA, Change Controls and Audits.
- Working to local procedures within a PQS system
- Experience working in a regulated environment for example: MHRA, FDA, HTA
- Understanding of GMP and working to GMP principals
- Ability to work efficiently and independently.
- Able to gather and trend data and apply scientific rationale where appropriate
- Good verbal and written communication skills
- Excellent organisation and attention to detail
Whilst not essential it may be an advantage if you have experience of:
- Ability to communicate effectively at different levels of the organisation
- Knowledge of Key Performance Indicators and reporting them to senior management
- Able to build good interpersonal and cross functional relationships to facilitate a quality culture.
Remuneration & Benefits
The salary for the Senior QA Associate 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 £30,000 to £35,000 range together with an attractive bonus and benefits package.
If you would like to join us as Senior QA Associate at this critical time in our development 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.