Quality Control Scientist I / II

We are working with a partner who seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.

THE ROLE - Quality Control Scientist I / II

The QC Scientist is accountable for participating in the effective running of daily operations in its Quality Control Laboratories. This role will report to Senior Scientist / Principal Scientist Grade and we’re looking for a talented and highly motivated individual with experience of Quality Control in the cell therapy setting (preferred). He/she should also have significant understanding of the regulatory aspects of the day-to-day workings in a busy QC laboratory including supporting studies e.g., stability assessment and transferring, qualifying / validating phase appropriate assays as fit for purpose to support clinical manufacture.

MAIN RESPONSIBILITIES:-

* Support Clinical Trial manufacturing through QC testing across multiple disciplines including microbiology, mammalian cell culture, flow cytometry, qPCR and potency testing.

* Lead quality actions relating to QC activities e.g., Invalid Assay / RCA / OOS / Deviations / Change controls.

* Lead the qualification and validation of test methods and processes to ensure their suitability for use in support of Clinical Trial manufacturing.

* Adhere to Good Documentation Practices in the recording of data and authoring of reports.

* Lead the selection and purchase of appropriate QC laboratory equipment.

* Lead equipment qualification activities

* In conjunction with the Tech transfer team and lead the technology transfer of QC test methods from the Analytical Development Group

* Design and execution of QC stability programmes

* Lead best practice in the department and become a key contact for the mentoring and training of more junior members of staff.

* Act as GMP ambassador, take responsibility for ensuring GMP compliance and adoption of GMP principles e.g., right first time.

* Lead activities to ensure close working with Analytical development and QA to ensure timely completion of all objectives.

* Authoring of SOP’s and reports and regulatory documentation e.g., CMC module, as required.

* Any other duties as required (post consultation) e.g., Quality Council representative.

* The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company.

EXPERIENCE WE ARE LOOKING FOR:-

* Experience from a directly relevant biotechnology or pharmaceutical industry

* Experience of working in a busy laboratory environment

* D or MD/ Ph.D in relevant scientific discipline, Master’s degree or native equivalent with 5+ years of directly related experience or; Bachelor’s degree in scientific discipline with 5 + years of experience

* Experience of phase appropriate analytical method transfer, qualification, and validation (ICH) for the batch release and stability testing of cell-based therapies

* Experience of the design and implementation of phase appropriate stability studies

* Understanding of critical process parameters (CPP), critical quality attributes (CQA), comparability etc. relating to manufacturing process

* Skills/Specialist knowledge Experience with a range of biopharmaceutical and cell-based techniques including some or all: Aseptic technique, Sterility testing, Cell Counting, Flow cytometry, PCR, Mammalian cell culture, Potency testing

* Significant understanding of cell biology and immunology (preferred)

* Strong verbal and written communication skills.

* Flexible, self-motivated, and focused on team outcomes.

* Strong understanding of GMP regulations.

* Excellent organisational skills with the ability to present results clearly and logically, working co-operatively as part of a team, as well as independently.

* Excellent attention to detail and ability to accurately follow SOPs.

* Commitment to high quality work.

Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees