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QC Analyst - Product Testing job in Manchester at Instil Bio (UK)

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QC Analyst - Product Testing at Instil Bio (UK)

QC Analyst - Product Testing

Instil Bio (UK) M13, Manchester, Greater Manchester, Greater Manchester Full Time
£28,000 - £38,000 / year
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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.

Quality Control Analyst - Product Testing

We now have an excellent opportunity for an experienced QC Analyst to join the team in Manchester. Reporting to the QC Supervisor you will be responsible for performing, reviewing and recording quality control assays ensuring safety, efficacy, dose and purity of product.

Key Responsibilities Include (but not limited to):

* Performing assays to measure key quality attributes of product including:

* manual flow cytometry assays

* automated cell counting, viability and phenotyping assays

* endotoxin assays

* mycoplasma assays

* sterility assays

* 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

Working Patterns: Full time Role 37.5 hours/week – day shift working will be required for periods (shift allowance will be paid)

Relevant Education Skills and Experience

In order to be successful in the role of Quality Control Analyst - Product Testing it is envisaged that you will possess the following qualifications, skills and experiences:

* B.Sc. or equivalent, in a relevant discipline

* 2+ years QC experience in a pharmaceutical industry

* Experience authoring, reviewing, and implementing methods and/or standard operating procedures in the quality control environment

* Knowledge of EMA Eudralex Volume 4 GMP requirements for manufacture of IMP biological therapeutics (EU GMP guidelines Annex 13)

* 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:

* Experience of flow cytometry

* Experience of cell-based potency assays

* Experience of automated Sterility/Endotoxin testing methods

* Knowledge of EMA Eudralex Volume 4 GMP requirements for manufacture of Advanced Therapy Medicinal Products (EU GMP guidelines Part IV))

* MHRA and HTA regulations associated with cell therapy products

Remuneration & Benefits

The salary for the Quality Control Analyst - Product Testing 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 £33,000 range together with an attractive bonus and benefits package. If the role is moved onto day shifts there will be an additional shift premium added to the salary.

Application Process

If you would like to join us as Quality Control Analyst - Product Testing 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
 

Recommended Skills

Product Quality Assurance
Sterility
Automation
Manuals
Testing
Data/Record Logging
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Job ID: 213670301

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