EVOX THERAPEUTICS - BACKGROUND

Evox Therapeutics is a privately held, Oxford-based biotechnology company focused on harnessing and engineering the natural delivery capabilities of extracellular vesicles, known as exosomes, to develop an entirely new class of therapeutics. Backed by leading life sciences venture capital groups and supported by a comprehensive intellectual property portfolio, Evox’s mission is to positively impact human health by creating novel exosome-based therapeutics for the treatment of various severe diseases with limited options for patients and their families. Evox has created substantial proprietary technology to modify exosomes using various molecular engineering, drug loading, and targeting strategies to facilitate targeted drug delivery to organs of interest, including the brain and the central nervous system. Exosome-based drugs have the potential to address some of the limitations of protein, antibody and nucleic acid-based therapies by enabling delivery to cells and tissues that are currently out of reach using other drug delivery technologies, and Evox is leading the development within this emerging therapeutic space.

For further information visit: www.evoxtherapeutics.com

JOB DESCRIPTION

Department: Process Development/CMC

Reports to: Senior Director- Process Development

Direct Reports: 6-8

Location: Oxford Science Park

MAIN PURPOSE OF JOB

We are seeking an ambitious, highly motivated, and experienced Biochemical engineer / Scientist with a background in biologics scale-up and production to lead our Product Scale-up and Supply team, this role will be responsible for intermediate scale up and provision of research grade materials. The team provides purified exosome development materials required for our in-vitro and in-vivo studies and supports the Discovery Research and CMC activities. The team will also be responsible for generating process demonstration batches at pilot scale and manufacture of materials for ‘IND enabling’ studies, at scales ranging from 10-200L scale using both adherent and suspension systems. This role will be responsible for defining quality and quantity requirements from project teams, working with technical leads in USP/DSP Development and Analytical Development teams. The remit includes to establishing ‘research’ manufacturing batch records, production scheduling, manufacture of high-quality material, in-process testing and on-time delivery to internal stakeholders. Also, the team will be responsible for the Technology Transfer of our Bioprocesses to our partner CDMOs for GMP manufacture.

We are looking for individuals interested in working in a Biomanufacturing environment 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 Senior Director, Process Development.

KEY ACCOUNTABILITIES

• Lead and manage a team of scale-up and production Scientists / Process Engineers to deliver ‘on-quality’ and ‘on-quantity’ materials to stringent timelines.
• Ensuring the team are appropriately trained and mentored and maintain high quality documentation to support regulatory submissions.

• Leveraging data analysis to identify opportunities for continuous process improvement.

• Responsible for the resolution of all technical and scientific issues that affect, or have the potential to affect, the delivery of materials to internal project teams and partners ensuring early visibility and awareness into implementation risks, identifying preventative measures, investigating, and troubleshooting equipment.
• Delivery of non-clinical manufacturing reports ensuring timely completion and high-quality documentation.
• Promote a culture of Right First Time and Operational Excellence.
• Ensure a healthy and safe working environment and compliance to GMO/ACDP requirements.

PERSON SPECIFICATION

Education and Qualifications:

• PhD/ EngD or BSc/MSc (+15 years’ experience) in Biochemical Engineering, Biotechnology, or in a related field.

A highly motivated ambitious Scientist/ Engineer with:

• Ability to work independently and lead and motivate others.
• Good conceptual, analytical thinking, problem solving, and organisational skills.
• Be on the cutting edge of Bioprocess manufacturing, and up to date with technical advancements in the field
• 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 Bioprocess Development and Scale-up. Ideally, the candidate will have a broad experience of Drug Substance and Drug Product manufacture and inter site technology transfer.
• 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).

Desirable

• Knowledge of statistical process control, multivariate analysis, and/or process analytical technologies techniques for biologics processes.
• An understanding of the principles of GMP manufacturing, aseptic processing, and fill finish.

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.