Reports to: CEO
MAIN PURPOSE OF JOB
The VP/SVP Process Development will report to the CEO and there is considerable flexibility around the level at which this individual can be appointed. The role will evolve over time and will be shaped by the appointed candidate. The candidate will be a key member of the Evox executive team (Senior Leadership Team).
The VP/SVP candidate will lead an internal team of 50+ people covering everything from vector design, cell line development, upstream processing, downstream processing, analytics, and manufacturing. The candidate will also interact closely and oversee work with external CMC manufacturers and service providers. He or she will also interface closely with other departments within Evox including Research, Translational Pharmacology, Clinical, and Project Management.
As Evox moves forward, the ability to provide strategic and tactical input into the CMC section of regulatory dossiers and to represent Evox in front of the global regulatory authorities will become a key element of this role. Another key strategic element will involve developing and implementing a plan for Evox’s proprietary late stage clinical and commercial manufacture of drug-loaded exosomes.
- Key member of the Senior Leadership Team (SLT) to help define overall Evox strategy with a particular emphasis on R&D and CMC-related issues.
- Define, articulate and implement the Process Development, Analytical, Manufacturing and Supply Chain strategy for Evox Therapeutics, including how best to resource and what future areas of work should be prioritised.
- Review current processes and capabilities with a view to ensuring that they meet the needs of the business and comply with relevant regulatory requirements.
- Continue to transform bench science into early clinical/commercial operations for preclinical and clinical needs across a broad range of areas.
- Use expertise in upstream process, downstream process, analytics and other aspects of CMC to inform project decisions.
- Continue to build, lead and develop the in-house manufacturing team, ensuring they have the skills and experience to meet the business needs.
- As a core member of the executive team be responsible for identifying issues and managing the entire CMC process to ensure that they are resolved, including managing the related third party CMC issues.
- Represent CMC to the Board and to current / future pharma partners and investors.
- Working across the organisation, establish and manage CMC-related project deliverables, timelines, budget and the supervision and mentoring of team members.
- As relevant, the identification, selection and management of relationships with external CMC organisations to enable advancement of Evox’s pipeline and continued development of its exosome platform.
- Provide input into relevant CMC documentation, ensuring that technical and scientific information, meets all regulatory requirements. Represent Evox with international regulatory authorities.
The ideal candidate will be an experienced biopharmaceutical development and manufacturing leader with specialist knowledge in relevant technology areas and in the regulatory aspects of the manufacturing of complex biologics, including cell therapies, gene therapies, RNAi, and mRNA etc. Experience of drug delivery systems (e.g. nanoparticles) will be useful.
Experience & knowledge
- Broad experience as a technical expert in the development and manufacture of biological products, across process development, analytical development and formulation development.
- Experience from another “early” company in a similar stage of company maturity, possibly with added experience from a global pharmaceutical company.
- Demonstrated understanding of regulations and guidelines governing pharmaceutical development, including the ability to apply these to overall pharmaceutical development activities.
- Ideally subject matter expert in the bio pharmaceuticals field, but with a good understanding broadly across development and multiple technologies is a must.
- Previous experience with contracting with external partners is essential.
- A successful track record of selecting and managing CDMOs, ensuring early identification of potential issues and contributing to technical solutions.
- A good regulatory background, preferably within cell and gene therapy products.
- Experience in the provision of CMC input into regulatory dossiers and of answering CMC related questions from global regulatory authorities.
- Experienced in working and managing in a changing, project driven environment that occasionally develops in unexpected ways.
- An entrepreneurial and dynamic person, with solid work capacity and an ability to make independent decisions within the framework and guidelines of the organisation.
- The ability to represent the company and its manufacturing activities at a senior level, both internally and externally.
- A person who is able to add value to and challenge their internal colleagues and their external business partners, and a person who is used to working with and in effective organisations.
- The person should possess a good degree of personal maturity, business insight, social and people skills that will assure the support and respect of team, peers and management and external partners coupled with an ability to adapt to other personalities in a respectful manner that is conducive to goal achievement.
- A team-player who is comfortable with delegated responsibilities and resources.
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.