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
Department: Process Scaleup and Supply CMC
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 Biochemical Engineer with a background in bioprocessing scale-up and production to play a key role in our Process Scale-up and Supply team, responsible for intermediate scale up and provision of research grade materials. The team provides purified exosome development materials required for in-vitro and in-vivo studies – supporting Discovery Research and CMC activities. The team are accountable 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. Also, the team are responsible for the Technology Transfer of our bioprocesses to third party CDMOs for GMP manufacture. In this role you will specialise in the successful development and scale-up of our downstream and purification process unit operations as well as aseptic processing and fill/finish. The successful candidate will also be able to broaden their experience within the Process Scaleup and Supply team in other areas of the manufacturing process such as cell culture and harvest.
This is an exciting opportunity for a talented engineer to take a leading role in the development of novel and potentially transformative bioprocesses for a new modality of biotherapeutic products. The team adapts and interprets processes for scaleup for future transfers to manufacturing facilities and liaises with the research functions to support early development and clinical development.
We are looking for individuals interested in working in a biomanufacturing environment who will thrive in a highly agile and start-up environment, who are 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 Group Leader Process Scaleup and Supply
- Lead the implementation, optimisation, and training of DSP processes within the Process Scaleup and Supply team to ensure delivery is ‘on-quality’ and ‘on-quantity’ to meet stringent timelines.
- Provide scientific and technical insight to assist process intra-site and inter-site technology 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 bioprocesses processes for the manufacture of biologics.
- Deliver product specific and platform DSP documentations, batch summary presentations and reports ensuring appropriate quality of documentation to support inclusion of data and information into 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 bioprocessing 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 Biochemical Engineering, Biotechnology, or a related field.
A highly motivated ambitious scientist with:
- Ability to work independently.
- Good conceptual, analytical thinking, problem solving, and organisational skills.
- Be on the cutting edge of bioprocess manufacturing and use of single-use technologies, 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 a 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
- PhD and 3+ years relevant industrial laboratory and scale-up experience in biologics and/or cell/viral vector product downstream process development or BSc/MSc with 5+ years relevant industrial experience as above.
- Experience in downstream research/process development or protein purification, from cell culture harvesting through to purified product. This would preferably have been gained working with protein biologics and/or viral vectors.
- Experience with preparative chromatography systems and a good understanding of chromatography techniques e.g., IEX/SEC/HIC/Affinity and Unicorn software is required.
- Experience and understanding of the use and scale-up of tangential flow filtration systems is essential.
- Hand-on experience in the implementation of single-use technologies and assemble in a production setting would be ideal.
- 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 ideal but not essential.
- Knowledge of regulatory requirements for the development and manufacture of biologics especially ATMPs 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.