Department: CMC- Process Development and Supply
Reports to: Group Leader- Process Scaleup and Supply
Direct Reports: N/A
MAIN PURPOSE OF JOB
We are seeking an ambitious, highly motivated, and experienced Scientist to play a key role in the development and research of exosome production. This role is within the Process Scaleup and Supply team and would specialise in USP cell culture as well as other duties within the Process Scaleup and Supply team such as preparative purifications.
This is an exciting opportunity for a talented scientist to take a leading role in the development of de novo processes for a new class of biotherapeutic products. The team adapts and interprets processes for scaleup for future transfers to manufacturing facilities and liaises with research functions to support early development.
We are looking for an individual who will thrive in a start-up environment, be able to coach 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 Group Leader Process Scaleup and Supply.
- Lead the implementation, optimisation, and training of USP cell culture processes within the Process Scaleup and Supply team to ensure high quality materials are produced that are suitable for in-vivo studies.
- Provide scientific and technical insight to assist process transfers into and out of the Process Scaleup and Supply team – for example interpreting and executing process descriptions and supporting the transfer to cGMP manufacturers.
- Contribute to the resolution of technical and scientific issues that affect, or have the potential to affect, the supply and execution of upstream processes for the manufacture of biologics.
- Deliver product specific and platform USP documentation, batch summary presentations and reports ensuring appropriate quality of documentation to support inclusion of data and information in regulatory filings.
- Work collaboratively with Research, Cell Line Development, Upstream Process Development, Downstream Process Development, Analytical Development, and Quality to develop and characterise new techniques at scale and recommend alternative approaches and potential solutions to processing issues.
- Lead and implement operational excellence initiatives to shape our environment and ways of working.
- Champion and ensure healthy and safe working practices are implemented in the laboratory to ensure 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.
- 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
- Relevant industrial laboratory experience in biologics and/or cell/viral product upstream process development.
- Experience in upstream, and protein expression in stirred tank bioreactors, from cell thaw through to primary recovery. This would preferably have been gained working with protein biologics and/or viral vectors.
- Experience with single use stirred tank bioreactors and associated software
- Experience of transient expression
- Experience of routine analytical techniques such as SDS-PAGE, Western Blotting and biochemical assays is desirable.
- Experience of ELISA, cell-based assays, HPLC, NTA and flow cytometry would be a bonus.
- Knowledge of regulatory requirements for the development and manufacture of biologics using from mammalian cell culture is desirable.
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.