Deputy QC Manager – Product Quality

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.

Deputy QC Manager – Product Quality

Instil Bio is seeking a driven and experienced Deputy QC Manager – Product Quality, reporting to the QC Manager, to ensure on-time, compliant reporting of product specific assays for product release and in-process control monitoring.  This individual will hire and train staff, develop KPIs for the team and supervise the associated laboratory. This will include management of both functional and personnel issues.

The candidates must have experience meeting regulatory expectations (ICH) related to product quality testing. 

Responsibilities (include but not limited to):

  – Authoring Standard Operating Procedures and ensuring QC Scientists and Technicians have adequate training

  – Hire the team and schedule workloads to deliver on-time testing results 

  – Transfer-in methods developed by the analytical team, transfer methods to other QC laboratories as required

  – Establish, qualify or validate QC assays in a phase appropriate manner, for each required product and sample type, in accordance with ICH Guidelines

  – Establish a culture of continuous improvement; continuously assess and enhance department and laboratory processes per change control procedures, to ensure that the product quality laboratory complies with the GMP license and operates to regulatory and quality expectations

  – Perform investigations as required, implement changes per change control adhering to the quality system

Requirements:

  – BSc, or MSc level qualification in a relevant biological sciences discipline

  – At least 6 years GMP QC laboratory experience

  – At least 2 years of direct management experience

  – Experience performing flow cytometry and cell-based potency assays

  – Experience performing lot release testing for cell therapy, gene therapy, biopharmaceutical or vaccine products

In addition to the above, it is beneficial if you have knowledge of:

  – MHRA and HTA regulations associated with cell therapy products

  – Experience with either PCR or ELISA assays

  – Familiarity with microbiological testing

Remuneration & Benefits

The salary for the Deputy QC Manager – Product Quality 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.

Application Process

If you would like to join us as Deputy QC Manager – Product Quality 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.