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 transformative modality of therapeutics. Backed by leading life sciences venture capital groups and supported by an extensive intellectual property estate, Evox’s mission is to positively impact human health by creating novel engineered exosome-based therapeutics for the treatment of various severe and rare diseases with limited options for patients.
Evox has created a substantial proprietary DeliverEX™ technology platform to drive the clinical development of engineered exosomes to develop novel transformative therapeutics in their own right, Engineered exosome-based therapeutics 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 conventional drug delivery technologies,
For further information visit: www.evoxtherapeutics.com
Reports to: Director, Product Development & Supply
Direct Reports: 3-4
MAIN PURPOSE OF JOB
We are currently looking to recruit an Group Leader/Associate Director – Upstream Process Development to join our growing Product Development and Supply (PDS) team within CMC, which comprises of talented scientists and engineers with extensive experience in bioprocess development and scale-up and product characterisation.
As Group Lead/Associate Director of Upstream Process Development you will provide scientific technical leadership and subject matter expertise to help drive understanding of our adherent and suspension mammalian cell upstream processes from development laboratory, through to pilot and into manufacturing.
This is an exciting opportunity for a successful technical SME to work within a new and challenging therapeutic area. The individual we are seeking is one who will thrive in a start-up environment, working collaboratively to overcome significant technical challenges with innovative solutions as well as being able to lead and motivate a team to deliver its objectives on-time and to the required quality.
This position is based at Evox Therapeutics R&D Laboratories in the Oxford Science Park, Oxford, UK and reports to the Director, Product Development and Supply.
- Lead and manage the Upstream Process Development team, managing performance and development, training, resource planning, recruiting, motivating, and building a strong high-performance team
- Accountable for the team’s performance in line with group and Company objectives, ensuring all work is delivered and reported in a timely manner to facilitate in-house and client-facing development programmes
- Provide scientific technical leadership in the development, optimisation and scale-up of mammalian cell adherent and suspension manufacturing platform process (including fed-batch and perfusion systems from 2L to 2m3 scale)
- Responsible for collaboratively providing scientific and technical leadership across departments regarding upstream process development and scale-up, and tech transfers internally for internal pilot scale production or to external CDMOs for cGMP manufacture
- Proactively identify project risk and issues to the relevant internal stakeholders and external collaborators at an early stage; lead/participate the resolution of technical and scientific issues, quantitative project risk/benefit analysis and decisions.
- Ensure the team deliver appropriate quality documentation and reports to support IP or regulatory filings.
- Ensure all work is performed in compliance with Evox’s QMS and HSE guidelines
- Represent Upstream Process Development at partner meetings, regulatory inspections, and site visits by third parties
- Champion new technologies and keep up to date with current literature and thinking.
Education and Qualifications:
- PhD or equivalent degree in a relevant Science (e.g. Biological sciences, Biochemical Engineering, Virology, Molecular/Cellular biology) with extensive experience.
- Excellent technical understanding of biopharmaceutical process development and manufacturing
- A broad understanding of the biopharmaceutical product development life cycle
- Excellent knowledge of the regulatory requirements for analytical work (e.g. ICH, product specifications, stability testing guidelines etc.)
- A broad and deep understanding of the full life cycle of the biopharmaceutical development of a product and manufacturing
- Excellent knowledge and experience of cell culture development, optimisation and scale-up.
- Ability to influence at high levels within CMC and across Evox including Research and Translational teams.
- Ability to work in a high paced team environment, meet deadlines, and prioritise work from multiple projects.
- Strong interpersonal and communication skills with demonstrable 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.
- Proven leadership, data analysis and trending skills including use of JMP® statistical software or equivalent
Experience & knowledge
- Will need to have proven direct industrial laboratory experience in biopharmaceutical development
- Extensive experience in pre-clinical development, mammalian cell culture development using a broad range of single use adherent and suspension bioreactor systems is essential
- Strong technical expertise of process development and scale-up, with a track record gained in mammalian upstream process development to support clinical development and commercial supply is preferred. Experience and knowledge of media and feed development would be ideal.
- Extensive knowledge and experience of working with adherent and suspension processes in a development setting is essential; fed batch or perfusion cell culture processes would be ideal.
- A good working understanding of analytical methods to monitor cell culture processes (in-process testing, at-line process monitoring) and the use of QbD/DoE approaches.
- Experience working with different molecules across different modalities (proteins, viral vectors, mAbs, cells) would be preferred
- Strong communication skills with the ability to lead and collaborate cross functionally in delivery of projects
- Knowledge of regulatory requirements for the development and manufacture of biologics using mammalian cell culture. Previous experience in supporting IND, MAA and/or BLA regulatory submissions would be ideal
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.