Quell Therapeutics is a London based, private biopharmaceutical company seeking to deliver truly innovative, life-changing therapies for our patients. Our vision is to build a major, global cell therapy business, delivering 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.
Job Description
The Scientist Ii - Aalaytical Developement is accountable for participating in the effective running of Quell’s daily operations in its Analytical Development Laboratories.
This role will report to Senior Scientist / Principal Scientist Grade. We are looking for a talented and highly motivated individual with experience of Analytical Development in the cell therapy setting. He/she should also have core skills in molecular biology and a good understanding of the regulatory aspects of developing and evaluating molecular biology assays (qPCR and dPCR) as fit for purpose for transfer to a QC laboratory environment for PhI/II clinical manufacture.
Key Responsibilities:
- Collaborate with other team members and contribute to the development of analytical methods suitable for the analysis of high-quality cell-based therapeutic products.
- To be the recognised point contact for molecular biology assays in the AD team.
- Lead assigned objectives with minimal supervision.
- Lead the development of analytical methods suitable for the testing of cell-based products.
- Lead the evaluation of test methods as fit for purpose for transfer to the QC environment.
- Ability to manage multiple projects simultaneously and cross-functionally.
- Plan and coordinates activities of reports to meet departmental requirements.
- Document analytical method development activities in laboratory notebooks and author analytical method development reports to support regulatory documentation.
- Contribute to analytical method transfer activities co-ordinated by the MSAT team.
- Work with external service providers.
- Maintain a high-level of professional expertise through familiarity with scientific literature and best industry practices.
- Manages activities of technicians, research associates and scientist Level 1 (20% of time).
- Lead in presenting and defending data in working teams and at lab meetings.
- 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) • Core skills in Molecular Biology (E)
- Experience from a directly relevant biotechnology or pharmaceutical industry (E)
- Experience of working in a busy laboratory environment (E)
- Ph.D or MD/ Ph.D in relevant scientific discipline with +5 years academic or industry related experience, Masters/Bachelor degree or native equivalent with 10+ years of directly related experience (E)
- Minimum of 3 years’ experience in an Assay Development Role (E)
- Experience developing, implementing, and evaluating molecular biology assays as fit for purpose (ICH) for the analysis and characterisation of cell-based therapies (E).
- Understanding of critical process parameters (CPP), critical quality attributes (CQA), comparability etc. relating to manufacturing process (P). S
- Skills/Specialist knowledge and/or experience with a range of biopharmaceutical and cell-based techniques including some or all of: Aseptic technique, Sterility testing, Cell Counting, Flow cytometry, PCR (ddPCR, dPCR, qPCR), Mammalian cell culture (E)
- Good understanding of cell biology and immunology (E)
- Excellent Problem-Solving Skills (E)
- Ability to interpret complex data and implement new work methods (E)
- Strong verbal and written communication skills (E)
- Flexible, self-motivated, and focused on team outcomes (E)
- Understanding of and familiarity with ICH regulations as applied to Assay Development / evaluation (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)
Why Quell? We are an exciting, growing biotech company with a culture centred around Innovation, Integrity, Collaboration, Accountability, Respect and, last but not least, having Fun. Our ambition is to be the leading cell therapy company in the Immune Dysregulation field. At Quell Therapeutics you will find highly talented people who live and breathe our culture and support you in your personal growth. More information can be found on www.quell-tx.com.
