ABOUT AVAILABLE POSITIONS
Northreach are partnering with an exciting biotech company specialising in developing of engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system.
Their mission is to bring 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.
Key Responsibilities - Quality Control Team
QUALITY CONTROL TEAM
We are looking for talented and highly motivated individuals with experience of Quality Control in the cell therapy setting. They 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.
- 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
THE IDEAL CANDIDATES
- Experience from a directly relevant biotechnology or pharmaceutical industry (E)
- Experience of working in a busy laboratory environment (P)
- Ph.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 7 + years of experience (E)
- Experience of phase appropriate analytical method transfer, qualification, and validation (ICH) for the batch release and stability testing of cell-based therapies (E).
- Experience of the design and implementation of phase appropriate stability studies (E)
- Understanding of critical process parameters (CPP), critical quality attributes (CQA), comparability etc. relating to manufacturing process (E).
- 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 (E)
- Significant understanding of cell biology and immunology (E)
- Strong verbal and written communication skills (E)
- Flexible, self-motivated, and focused on team outcomes (E)
- Strong understanding of GMP regulations (E)
- Excellent organisational skills with the ability to present results clearly and logically, working co-operatively as part of a team, as well as independently (E)
- Excellent attention to detail and ability to accurately follow SOPs (E)
- Commitment to high quality work (E)