Skills: Flow Cytometry, Cell Culture, GMP, GLP, Manufacturing, Biotechnology, Biopharmaceuticals, Cell Therapy, Gene Therapy
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.
Instil Bio is hiring a driven and experienced QC Bioanalyst to the QC Product Testing team in Manchester, UK. You will report to the QC Manager. You will be responsible for performing cell based assays, managing sample receipt, and helping to maintain the testing of samples by flow based methods in the QC laboratory. Full training in the use of Flow Cytometry will be provided. Your work will directly support and advance the Instil Bio pipeline of life-saving cell therapy product during clinical trials (first-in-human and pivotal).
Main Duties & Responsibilities (include but not limited to):
- Product quality testing using flow cytometric methods
- Troubleshooting analytical instruments and methods
- Performing method qualification experiments
- Performing method transfer assays with input from analytical development
- Deviation and investigation support, including unexpected or out of specification results
- Authoring and reviewing SOPs
- Performing routine record review for in-process and release testing
- Managing data for analysis and trending
- Logging and tracking samples provided by Production for QC testing
- Ensuring the QC testing laboratory is maintained correctly with regular cleaning and instrument checks
Requirements and Recommendations:
It is likely to succeed in the role of QC Bioanalyst you will hold a Bachelors or Masters degree with at least 2 years analytical or QC experience in the biopharmaceutical industry.
It is critical that you have:
- Experience of QC analysis for biological products
- Knowledge of immunology
- Experience authoring, reviewing, and implementing methods and/or standard operating procedures in the QC environment
- Knowledge of ICH Q2R1 and cGMP
Full training in the specific cell based assays and use of flow cytometry for product analysis will be provided but it may be an advantage if you have:
- Experience with method qualification and method transfer
- Knowledge of mammalian cell culture
- Familiarity of MHRA and HTA regulations, particularly with cell therapy products
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Excellent IT skills
Remuneration & Benefits
The salary for the QC Bioanalyst 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.
If you would like to join us as a QC Bioanalyst in our Product Testing team during this exciting period of growth and you believe 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.
Related skills: Biology, Cell & Molecular Biology, Life Science, Laboratory, Research
You must be eligible to work in the UK. Learn more
- Employer: Instil Bio (UK)
- Updated: 9th October 2020
- Expires: 6th November 2020