Research and Development Manager – Cell and Gene Therapy
Galway, Ireland | Permanent full-time role | Salary commensurate with experience
HiTech Health focuses on enabling healthcare companies to develop, launch and supply products to the market. The company was established in 2013, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports cell and gene therapy companies develop, manufacture and supply life-changing therapies to patients.
We are seeking to hire a Research and Development Manager for our expanding laboratories in Galway. This is an exciting role for a highly motivated individual to join a growing organisation and be deeply involved in leading the development of new process and analytical methods. The candidate will work closely with clients and other functional units within Hitech Health including production to support the development of a range of cell and gene therapy products.
- Lead a team of scientists focused on product development for the cell and gene therapies for our clients. This includes the training and development of the scientists for a growing company.
- Design experiments independently and in multi-disciplinary teams to efficiently test hypotheses and rapidly iterate to ensure optimal solutions for clients.
- Execute experimental plans individually and with the team.
- Drives key initiatives including trouble-shooting Manufacturing challenges.
- Manage projects within the portfolio through the development process and ready for transfer to GMP manufacture.
- Lead the technical transfer from R&D/GLP into the GMP setting.
- Generate new ideas to expand the product portfolio.
- Proactively investigate and resolve problems, identifying root cause, and proposing process improvements.
- Optimize cell selection, gene delivery, and culture protocols for cell and gene therapy applications.
- Troubleshoot and optimize, develop alternative methods, and innovate.
- Document and analyse data and manage the R&D documentation in line with company and client requirements.
- Foster collaboration and team building, liaise with other business functions and clients to successfully transfer products.
- Coach and mentor scientists, remove roadblocks and create a highly functional team.
- Communicate with client companies including the development or project proposals, project status updates and reports.
- Stay up to date on new developments and regulations in the cell therapy field by studying the literature, attending conferences, and conversations with key opinion leaders and consultants.
- Lead in documentation for reports for clients and also for regulatory documentation filings.
- Create SOPs and Quality Control specifications based on the data obtained from R&D.
- MSc or Ph.D. in Science, with a focus on Cell and Gene therapy research and development.
- At least 6 years experience in a Cell and Gene therapy company in a Research and Development environment and including the management of a team of scientists.
- Strong knowledge of cell culture-based manufacturing, technology transfer, investigations of cell and gene therapies.
- Experience with manufacturing of cellular therapy products and viral production.
- Hands-on technical experience in all or most of the following; flow cytometry, Bioreactor technology, virial vector manipulation, RT-PCR/Q-PCR, Gel analysis, ELISA.
- Familiarity of US and European GMPs and Pharmacopeia.
- Proficient in technical writing and experience in creating R&D process documents; Analytical Development documents; Technical Transfer documentation and summary reports to support FDA and EMA filings.
- Experience working in a small-medium company and/or facility start-up.
- Knowledge of emerging technologies, trends, and methodologies.
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