We are seeking an ambitious, highly motivated and experienced biologics manufacturing scientist to lead our Non-Clinical Manufacturing team responsible for laboratory scale through to pilot scale non-clinical manufacturing. This team provides purified exosome development material required for in-vitro and in-vivo studies – supporting Discovery Research and CMC through to scale-up process demonstration batches and manufacture of material for ‘IND enabling’ studies. The Non-Clinical Manufacturing team operates at scales ranging from material purified using pooled shake flasks through to large scale manufacture at 10-200L scale using both suspension and adherent systems that are coupled with platform DSP to produce formulated and filled ‘research’ drug product. You will be responsible for defining quality and quantity requirements from project teams, working with technical leads in USP/DSP development and Analytical Development to establish processing/testing approaches, establishing ‘research’ manufacturing batch records, scheduling, manufacture of material, in-process testing, on-time delivery of material, , reporting and inventory management including working with supply chain for shipments to CRO’s.
We are looking for an individual who will thrive in a highly agile and start-up environment, who is able to lead, motivate, innovate and will 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 establish a team of manufacturing scientists as well as taking on a ‘hands-on’ approach to deliver project material requirements.
- Ensuring the manufacturing scientists are appropriately trained, coached and mentored and maintain high quality record keeping and documentation of experiments aligned with Evox data integrity policies.
- Provide scientific and technical leadership, in non-clinical manufacturing and ‘transfer-in’ of production and analytical protocols from Research, Process Development and Analytical Development - for example technology transfer, identification of risks, materials requirements, scale-up, and scheduling.
- Responsible for the resolution of all technical and scientific issues that affect, or have the potential to affect, the delivery of material to project teams ensuring early visibility and awareness into implementation risks, identifying preventative measures, investigating, and troubleshooting equipment.
- Deliver non-clinical manufacturing reports ensuring timely completion and high quality documentation.
- Work collaboratively with the technical and operational stakeholders, e.g. Project Managers/Programme Management, Research/Discovery, Cell Line Development, Upstream/Downstream Process Development, Analytical Development and Quality to ensure ‘on-time’, ‘on-quality’ and ‘on-quantity’ delivery, in line with the demands of the business.
- 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 and motivate 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
- Proven experience gained within direct industrial laboratory experience in biologics and/or cell/viral product manufacturing, upstream or downstream process development following PhD or 8+ years direct industrial laboratory experience as above following BSc/MSc. Ideally, the candidate will have broad experience of USP and DSP operations and scale-up, however, the candidate may have deep expertise in one aspect such as USP or DSP but would require good operational familiarity with the other.
- Demonstrated significant accomplishments, leading cross-functional, non-clinical or clinical manufacturing teams including scale-up manufacturing, technology transfer.
- Leadership experience gained managing a biologics manufacturing team.
- A good working understanding of analytical methods to monitor processes (in-process testing).
- Knowledge of statistical process control, multivariate analysis, and/or process analytical technologies techniques for biologics processes.
- An understanding of the principles of GMNP manufacturing
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.