We provide VISA support for candidates from the USA, Europe, Australia and Asia.
Director/VP of Process Development - Translation
We offer an exciting opportunity for a Director or VP Process Development (dependent on level of experience) to join our Translation Group, based in our new facility in London.
Resolution Therapeutics (RTx) is a biotechnology company developing macrophage cell therapies to treat inflammatory organ disease. The company's technology platform is based on over a decade's work by Prof. Stuart Forbes and Prof. John Campbell, and provides RTx with a leading position in macrophage biology and regenerative medicine.
In 2020, following a productive collaboration between Edinburgh's Centre for Regenerative Medicine, the Scottish National Blood Transfusion Service, and Syncona, RTx was launched with a £26.6m series A financing.
Today, RTx is a multidisciplinary team of experience scientists, engineers and entrepreneurs based in Edinburgh and London, working at the forefront of cell therapy and liver disease, supported by Syncona, Europe's leading life science investor.
In this role you will be accountable for the process development program for engineered macrophage cell therapy products for therapeutic applications starting with liver cirrhosis. You will work very closely with the Edinburgh based units to develop, translate and optimise the process designs as developed by R&D to a qualified manufacturing design suitable for routine manufacturing according to GMP standards.
Key responsibilities:
- Leading the company's Process Development group and activities
- As part of CMC leadership team provide strategic input into overall product development and manufacturing activities
- Provide guidance and invest in personal growth and development of process development staff
- Accountable to develop and execute a process development strategy that is phase appropriate for delivery of drug product through clinical phases and into commercialisation
- Accountable to develop and execute a characterisation and qualification program to build product know-how related to identification of and critically analysis for process parameters
- Manage the process development team of Scientists and Associates for development refinement and continuous improvement of the process, the unit operations, materials and process equipment used, including hands-on supporting data analysis and ad-hoc steering of experimental design and troubleshooting
- Accountable for translation of research protocols and interfacing with the Cell Engineering and Macrophage Biology Units to develop these standard operating procedures translating research protocols to the GMP environment
- Accountable for the qualification and validation program of the process
- Accountable for the documentation associated with the process development activities
- Accountable for technology transfer to CMO
- Accountable for the stability programs and generation of reference materials
- Responsible for supply agreements with outsourced suppliers
- Supporting the development of the Clinical Trial Dossier and regulatory-related documentation related to the analytical aspects of the cell therapy product(s), including QTPP, CTD, IMPD and risk assessments
- Writing patents, publications,
- Data analysis, definition of success criteria, summarising data for progress reports and trending.
- Provide high level reports and presentations to be presented in management or board meetings
You will report directly to the Chief Development Officer, and will build a team of scientists and associates that will grow with the progression of clinical programs. You will collaborate closely with Head of Analytical Development and Head of Quality within the Translation process group.
The successful candidate must have the following qualifications, skills, and experience:
- A PhD degree / or equivalent experience in cell biology, chemical engineering, or immunology or a related discipline or equivalent experience
- Minimum 5 year experience on director level in process development for ATMPs
- Proven track record in the biotech field, experience with working and delivering to company goals
- Ability and willingness to be actively involved in data analysis, interpretation and day-to-day management. Comfortable and able to bridge detailed data analysis to strategic and operational planning
- Proven ability to manage a team, with clear leadership skills
- Experience in Good Manufacturing Practice (GMP) settings
- An understanding of quality by design and developing an appropriate control strategy for products in development
- Proven track record of independent manuscript publication and/or patent submission as a first author
- Proven track record of experience with regulatory submissions through various phases of development and
- Proven track record in documentation generation, including compilation of standard operating procedures and test protocols
- Proven track record with different primary cell types and associated culture techniques
- Experience with differentiation and/or proliferation of primary cell culture
- Experience with single-use, automated and closed processing techniques
- Experience with bioprocess engineering and scale-up cultivation
Preferable skills/experience include:
- A working knowledge of immunology and chronic inflammatory diseases, preferably chronic liver disease
- Experience with technology transfer
- Experience in genetic stability testing
- Experience with flow cytometry techniques
- Understanding of aseptic processing
- Experience in a commercial laboratory environment
- Experience using cell processing equipment
- Experience with adherent and suspension bioreactor techniques
Selection process:
Following your application, an initial call will be scheduled by the Recruitment Partner before being shortlisted. If successful, you will be invited to start the interview process which consists of 3 stages:
- Initial meeting with the Hiring Manager and another member of the RTx team
- Presentation & panel interview
- Conversation with the CEO
Please be aware that due to the volume of applications, feedback will not be provided at the application stage.
Benefits:
Our competitive package includes pension, private health insurance and life assurance, as well as an opportunity to participate in the Company's incentive shares scheme.
