JOB DESCRIPTION

Department: Process Development/CMC

Reports to: Group Leader – Upstream Process Development

Direct Reports: N/A

MAIN PURPOSE OF JOB

We are seeking an ambitious, highly motivated Upstream (USP) Associate Development Scientist or Senior Associate Development Scientist, depending on experience, to join our team. This is a role where you will be able to apply your experience in a cutting-edge environment working for a growing company in an innovative environment. This is an exciting opportunity for a talented scientist to contribute to the development of novel, state-of-the-art mammalian cell culture upstream processes for exosome-based biotherapeutic products.

We are looking for an individual who is a motivated self-starter, who will thrive in a start-up environment, and be able to learn, 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 Upstream Process Development.

KEY ACCOUNTABILITIES

• Work closely with Upstream Development Scientists to design and execute experiments to develop and optimise mammalian cell culture in batch, fed batch and perfusion processes for exosome products.
• Performing cell culture for expansions and material supply using shake flasks systems, stirred tank (2-10L), WAVE and fixed bed bioreactors.
• Producing cell banks for Upstream development studies.
• Appling statistical approaches for process optimisation (DoE, QbD) using high throughput bioreactors (15/250ml ambr) and translation of small-scale results to process scale-up.
• Scale up of upstream processes (10-200L) to confirm process performance.
• Experience with routine analytical techniques such as SDS-PAGE, Western Blotting, biochemical assays and ELISA is desirable.
• Support technology transfer activities for commercial manufacturing.
• Ensure that all experimental and analytical data is documented following data integrity principles.
• Work collaboratively with Research, Cell Line Development, Downstream Process Development, Process Scale-Up and Supply and Quality to develop and establish new techniques and recommend alternative approaches and potential solutions to upstream process development issues.

• Ensure a healthy and safe working environment and compliance to GMO/ACDP requirements.

PERSON SPECIFICATION

Education and Qualifications:

• BSc/MSc in Cell Biology, Biochemistry, Biotechnology, Molecular Biology, Biological Sciences, Biochemical Engineering or a related field.

A highly motivated and 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

• BSc or MSc in relevant area with 0-3+ years relevant laboratory or industrial experience in biologics and/or cell/viral product process development
• Experience with suspension mammalian cell culture development and optimisation for batch, fed-batch and perfusion processes and scale up most probably gained in with protein and/or viral products would be a key asset.
• Experience in adherent cell culture, expansion and scale out would be advantageous but not essential.
• Experience with transient transfection, optimisation and scale up of viral vector products would be an advantage.
• Experience with basal medium and feed development, control and optimisation is an asset.
• Understanding and experience of development and establishment of in-process analytical methods as applied to mammalian cell culture processes is an asset.

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.