MAIN PURPOSE OF JOB
We are seeking an ambitious, highly motivated and experienced mammalian upstream process (USP) development Principal Scientist with a desire to continue to work ‘hands-on’ whilst leading and managing our ‘CMC USP’ team activities. The individual will be accountable for all aspects of USP process development. The scope of accountabilities spans working with cell line development in the evaluation of cell lines, the establishment of high titre high harvest quality USP production processes. The CMC USP team transfers and supports, as required, developed processes to internally to Research Manufacturing and externally to cGMP contract manufacturing organisations.
We are looking for an individual who will thrive in a start-up environment, be able to lead and motivate, be able to innovate and relish the sense of accomplishment each day brings in our exciting company.
This position is based at Evox Therapeutics facility at the Oxford Science Park, Oxford, UK and reports to the Vice President, Process Development.
Lead and grow a team of upstream process development scientists as well as working ‘hands-on’ to deliver project and USP platform development activities.
Ensure USP scientists are appropriately trained and maintain high quality record keeping and documentation of experiments aligned with Evox data integrity policies.
Develop, optimise and establish robust, scalable industry leading mammalian USP capability to produce high quality cell culture harvests containing high titre engineered exosome product aligned with the needs for downstream processing.
Provide scientific and technical leadership, in upstream process development and transfer into Research manufacturing or cGMP - for example process risk assessments, media and feed development, technology transfer and scale-up.
Lead resolution of technical and scientific issues that affect, or have the potential to affect, the development and execution of mammalian cell culture processes for the manufacture of biologics.
Deliver product specific and platform USP documentation, process flow diagrams and reports ensuring appropriate quality of documentation to support inclusion of data and information in regulatory filings.
Work collaboratively with Research, Cell Line Development, Downstream Process Development, Analytical Development, Research Manufacturing and Quality to develop and establish new techniques and recommend alternative approaches and potential solutions to cell culture issues.
Ensure a healthy and safe working environment and compliance to GMO/ACDP requirements.
Education and Qualifications:
PhD or BSc/MSc in Cell Biology, Biochemistry, Biotechnology, Food Science, Biological Sciences, Biochemical Engineering or a related field.
A highly motivated ambitious scientist with:
Ability to work independently and lead others.
Good conceptual, analytical thinking, problem solving, and organisational skills.
Ability to work in a high paced team environment, meet deadlines, and prioritise work from multiple projects.
Strong interpersonal and communication skills with demonstrated ability to work within a team environment.
Ability to balance multiple priorities and projects at the same time and be able to change priorities as needed by the business.
Experience & Knowledge
At least 5+ years direct industrial laboratory experience in biologics and/or cell/viral product upstream process development post PhD or 8+ years direct industrial laboratory experience as above post BSc/MSc.
Experience in mammalian upstream process development from cell stock ‘out of freeze’, seed train development and production bioreactor optimisation (media and feeds) for example gained for protein biologics and/or viral vectors, ideally exploiting PAT tools and applying QbD principles.
Experience with single use systems such as Wave, single use stirred tank bioreactors, ideally, microbioreactor (e.g. ambr15), <1L such as ambr250 and scale-up through to 2-200L scale SUB’s. Experience of scale-up of adherent cell culture processes would be a bonus.
Experience of development of batch, fed-batch processes. Experience of perfusion would be a bonus.
Experience in the application DoE. Experience of using JMP would be a bonus.
Knowledge of regulatory requirements for the development and manufacture of biologics using mammalian cell culture.
Familiarity with instruments commonly used in a USP laboratory such ViCell, spent media analysers, BGA, osmolarity, etc.
Leadership experience, ideally leading and managing an upstream process development team.
KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF
People with Purpose – We are innovative and creative in the way we work and deliver. We treat each other with respect and dignity and work collaboratively to learn from each other’s strengths.
Driven to Deliver – We strive to deliver our objectives, and then look for our next challenge. We recognise our achievements and celebrate our successes.
Agile and Accountable – We respond to challenges impacting our progress and find creative and innovative solutions to overcome obstacles. We are brave and not afraid to change our approach to achieve a positive outcome in optimum time.
Candid and Constructive – We communicate with honesty and transparency throughout the team. We value giving and receiving constructive feedback to each other and our partners.