Research and Development Manager – Cell and Gene Therapy – Galway

Research and Development Manager – Cell and Gene Therapy – Galway

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.

Responsibilities:

  • 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.

Essential Requirements:

  • 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.

 

TO APPLY, PLEASE CLICK HERE: https://my.hrduo.com/candidate-jobs/Hitech_Health_and_Deántusaiocht_Slainte_Hitech_Teoranta/816759042?tracker=LinkedIn

FOR MORE INFO: recruitment@hrduo.com

Recent News

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

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HiTech-Health awarded with government funding

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for ‘disruptive’ project

 

HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund (DTIF), administered by Enterprise Ireland. This award will support the development of a novel treatment for Knee Osteoarthritis with the potential to regenerate the damaged knee joint whilst providing long-lasting pain relief.

Dr Brian Harrison, MD Hi-Tech Health, “We are excited to work with Relevium and Prof Garry Duffy’s team on the process development, scale up and GMP manufacturing of this novel therapeutic candidate at our Galway facilities. With all parties in the local area, we believe this will strengthen our partnership and help with developing this novel Knee Osteoarthritis therapy.”

Dr Alison Liddy, Founder and CEO Relevium, “This funding will enable Relevium and our partners to develop this ground-breaking treatment that has the potential to transform the lives of people living with Knee Osteoarthritis.”

Professor Garry Duffy, NUI Galway, “My team at NUI Galway are delighted to be part of this project and to work with industrial leaders to develop an impactful solution for Osteoarthritis.”

Relevium Medical awarded with government funding

HiTech Health awarded with government funding

NUI Galway awarded with government funding

Read the full Irish Times article here: Government to provide €95m in funding for ‘disruptive’ projects

Find out more about Relevium: www.relevium-medical.com

Find out more about NUI Galway: www.nuigalway.ie/medicine-nursing-and-health-sciences/

Recent News

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

Stay Up To Date

Connect with us to receive the latest HiTech Health and industry updates.

HiTech Health and Anthony Nolan announce collaboration

HiTech Health and Anthony Nolan announce collaboration

HiTech Health and blood cancer charity Anthony Nolan have entered into an agreement to facilitate the development of novel cell and gene therapies.

Anthony Nolan Cell & Gene Therapy Services will support HiTech Health’s supply chain through the provision of a reliable, scalable source of high-quality starting material. Initially provision of cellular material will be for research and development (R&D) programmes with a view to scale up in the future to clinical application and manufacturing. The parties are open to collaboration with cell and gene therapy developers and will work with them to provide bespoke offerings specific to the client’s requirements.

Anthony Nolan Cell & Gene Therapy Services brings expertise in cell sourcing, selection and provision of high-quality starting material to complement HiTech Health’s end-to-end service from product development to manufacturing and launch of life-changing treatments.

In partnering we aim to support cell and gene therapy researchers and developers to bring life-saving treatments to patients who need them.

Diana Hernandez, Head of Immunotherapy Research at Anthony Nolan says: “This is a significant step towards establishing a sustainable chain in cell and gene therapy development as we move towards allogeneic therapies. This collaboration ensures supply of ethically sourced starting material to developers of new therapies, which we hope will improve the treatment and care of thousands of patients in the future. It also allows the parties to share information regarding quality attributes of the material, which can help inform future improvements.”

Aoife Duffy, Cell and Gene Therapy Operations Manager, HiTech Health says: “HiTech Health’s collaboration with Anthony Nolan will be a great benefit to our clients. Anthony Nolan’s reputation for supply of high quality starting materials provides assurance to our clients and collaborators that a robust supply chain is in place for the manufacturing and supply of Cell and Gene Therapy Products. With this collaboration with Anthony Nolan, we now have a supply of starting material that is crucial to enable manufacturing of these novel therapies. This collaboration adds to our current R&D experience and future expansion into GMP manufacturing. Our expertise in quality, QP approval, and management of product supply and logistics will also be an important role in this collaboration. We are very excited about this collaboration and are looking forward to the possibilities that we can achieve together with the ultimate goal of treating patients who have an unmet medical need.”

About Anthony Nolan Cell and Gene Therapy Services

Anthony Nolan is the pioneering charity that saves the lives of people with blood cancer and blood disorders who need a stem cell transplant. Anthony Nolan’s Cell and Gene Therapy Services aim to facilitate ethical research and development through the sourcing and supply of donor starting materials to researchers and developers. With a register of over 850,000 donors, a cord blood bank, and four decades of experience providing stem cells, Anthony Nolan has the infrastructure, the expertise, and the skills to support the needs of the cell and gene therapy industry

Website: www.anthonynolan.org/clinicians-and-researchers/cell-and-gene-therapy-services
LinkedIn: www.linkedin.com/showcase/anthony-nolan-cell-&-gene-therapy-services/
Contact: Katie Griffee, Business Development Manager – katie.griffee@anthonynolan.org

About HiTech Health

HiTech Health bring an in-depth knowledge and experience of Cell and Gene Therapy products, We offer a range of services to help develop and supply life-changing treatments. Our experts can provide comprehensive solutions and strategies for process development, supply pre-clinical products and quality control assay development. We also have the GMP experience and expertise including QP support to ensure GMP compliance and product release. We also have the demonstrated supply chain and logistics expertise to enable cell and gene therapy products to be imported into Europe and the UK.

Find out more about Cell & Gene Therapy: www.hitech-health.com/cell-and-gene-therapy/
Find us on LinkedIn: www.linkedin.com/company/hitech-health
Contact: Aoife Duffy, Cell & Gene Therapy Operations Manager – aduffy@hitech-health.com

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HiTech Health, SextonBio and MedInstitute announce collaboration

HiTech Health, SextonBio and MedInstitute announce collaboration

HiTech Health, SextonBio and MedInstitute announce collaboration to develop and publish workflows for integrating unit operations in cell therapy manufacturing using flexible automation systems.

Sexton Biotechnologies, in partnership with HiTech Health and Med Institute, is working towards continued innovations in flexible automation. As cell and gene therapy manufacturers move to close and automate processes, the challenge of integrating existing systems is a pain point for the industry. Flexible automation of traditionally manual process offers a new solution with lower capital expenditures and greater potential for downstream success.

HiTech Health is focused on product development, manufacture, launch, and supply of cell and gene therapies. Aoife Duffy, Cell and Gene Therapy Operations Manager, leads a team that has successfully developed multiple cell and gene therapy products.

“We think it is important to collaborate with other companies so that we can add to our expertise in operational activities,” said Aoife. “Cell and gene therapy products are expensive to develop and manufacture. Working with Sexton and the Med institute to bring the new fluid management system to the market will help with making processing more efficient. HiTech Health is bringing our extensive operational and GMP Manufacturing expertise to this collaboration. We are expanding our capabilities to cell and gene therapy process development and manufacturing. Additional expertise we bring to the collaboration includes quality, QP approval, and management of supply chain. In the end, we believe that this collaboration will lead to time and cost savings, along with greater downstream success in the manufacture of cell therapy products.”

Click here for more details.

Contact us to know more about HiTech Health!

HiTech Health is on a different level after refining elevator pitch

HiTech Health is on a different level after refining elevator pitch

Read the Business Post article “HiTech Health is on a different level after refining elevator pitch” with HiTech Health’s Managing Director Brian Harrison by clicking on the link below:

Read the full article here: https://www.businesspost.ie/smes/hitech-health-is-on-a-different-level-after-refining-elevator-pitch-03f7b65f

Contact HiTech Health here for more information.

Recent News

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

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Connect with us to receive the latest HiTech Health and industry updates.