Quality Control Scientist

ABOUT US

At Quell we 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.

OUR COMPANY

Quell was founded in March 2019 in partnership with six prominent immunological experts from King’s College London, University College London, and Hannover Medical School, and is led by Iain McGill, a leading pharmaceutical executive with extensive relevant experience, having spent most of his 25 years in the industry in immunology, including the areas of solid organ and cell transplantation. The Company was founded with initial series A financing, led by Syncona Ltd who committed $83M with a further $1M contributed by UCL Technology Fund.

THE ROLE

Quality Control Scientist I/II

The QC Scientist I is accountable for participating in the effective running of Quell’s daily operations in its Quality Control Laboratories. This role will report to Scientist II / Principal Scientist. We are looking for a talented and highly motivated individual with experience of Quality Control in the cell therapy setting. 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.

Key Responsibilities:

Support Clinical Trial manufacturing through QC testing across multiple disciplines including microbiology, mammalian cell culture, flow cytometry, qPCR and potency testing
Initiate quality actions relating to QC activities e.g., Invalid Assay / RCA / OOS / Deviations / Change controls
Responsible for 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
Assist / Advise with the selection and purchase of appropriate QC laboratory equipment
Participate with equipment qualification activities
Provide support the technology transfer of QC test methods from the Analytical Development Group
Support QC stability programmes
Be accountable for 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
Support 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

Skills and competencies (E – Essential P – Preferred)

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

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)

BENEFITS

• Holidays: 25 days per year
• Life Assurance: 4 x base salary
• Group Personal Pension: Auto enrolled at 4% employer contribution, 4% employee contribution
• Private Medical Insurance for your whole family
• Annual Bonus

PERKS

• Fantastic collaborative environment at Translation & Innovation Hub
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• $156 Million Investment including brand new lab equipment, innovative methods, and exposure to cutting edge technology
• Flexible working
• Fast paced and progressive company looking for future leaders and innovators