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 / QC Analyst - Microbiology
We now have a number of excellent opportunities for Senior / QC Analysts to join our Microbiology team. Reporting to the QC Supervisor you will work with the Manufacturing and QA teams to ensure appropriate microbiological testing of the cell therapy products produced by Instil Bio.
Key Responsibilities Include (but not limited to):
* Performing microbiological testing including:
* Environmental monitoring
* Deviation support, including unexpected or out of specification results
* Authoring and reviewing SOPs
* Input of data for analysis and trending
* Checking of data
* Logging and tracking samples provided by Production for QC testing
* Ensuring the QC testing laboratory is maintained correctly with regular cleaning and instrument checks
Relevant Education Skills and Experience
In order to be successful in the role of Senior / QC Analyst - Microbiology it is envisaged that you will possess the following qualifications, skills and experiences:
* B.Sc. or equivalent, in a relevant discipline
* 2+ years QC microbiology experience in a pharmaceutical industry
* Knowledge of GMP requirements for microbiology (EU GMP guidelines Annex 1, European pharmacopeia 2.6)
* Experience authoring, reviewing, and implementing methods and/or standard operating procedures in the quality control environment
* Ability to function efficiently and independently in a changing environment
* Self-motivated and willing to accept temporary responsibilities outside of initial job description
Whilst not essential it may be an advantage if you have experience of:
* Sterility testing
* Environmental monitoring in a cleanroom environment, including separative air devices
* Endotoxin testing
* MHRA and HTA regulations associated with cell therapy products
Remuneration & Benefits
The salary for the Senior / QC Analyst - Microbiology 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 £28,000 to £34,000 range together with an attractive bonus and benefits package.
If you would like to join us as Senior / QC Analyst - Microbiology 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
Product Quality Assurance
Software Quality Assurance (Sqa)