Do you want more variety and flexibility in your role? To work for a young and exciting Dublin based consultancy company? Then consider joining HiTech Health!
HiTech Health focuses on enabling healthcare companies to launch and supply products. The company was established in 2013 in Dublin, Ireland, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports healthcare companies from the development to the launch and supply of products.
This permanent position is an exciting role for a dynamic individual to join a growing organisation. The successful candidate will have the opportunity to work with a number of clients and to contribute to a variety of different projects.
The role of Cell and Gene Therapy Operations (CGTOM) Manager involves leading all cell and gene therapy operations for HiTech Health and for its clients. The CGTOM will be responsible for all ‘end to end’ CGT operations which includes selecting manufacturers to delivery of CGT products to clients.
- Working closely with clients to ensure that products (drug substance and drug products) manufactured meet compliance GMP and product efficacy and that these products are supplied and available to patients when required.
- Leading and further building a CGT expertise and organisation within Hitech Health.
- Development of business processes and systems to ensure successful manufacture and supply of CGT products for clients.
- Working with the quality team to perform any required internal/client investigations and the issuance of follow up reports (e.g. rejected batches, deviations, CAPAs, OOS).
- Ability to generate GxP documentation for approval by Quality to ensure successful manufacture and supply of CGT products. This includes agreements (QTAs) to ensure GMP compliance.
- Acting as a point of primary contact for clients.
- Advising and providing input to clients’ manufacturing and supply chain.
- Conducting CGT technical audits on behalf of clients and subsequent issuance of reports.
- Participating in cross-functional projects for the development and scale-up of products.
- Reporting directly to the Managing Director on a regular basis to ensure client’s goals are being met.
- Creating and delivering CGT training internally or externally on behalf of clients.
- Third level Degree in Science or relevant discipline.
- Minimum 10 years of experience in Pharmaceutical industry in a Cell and Gene Therapy manufacturing/supply.
- Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.
- Auditing experience of suppliers in CGT biopharma industry is desirable.
- CGT compliance knowledge and experience.
- Experience in participation in regulatory audits is desirable.
- Experience in people management is favourable.
- Ability to critically assess situations and make strategic decisions.
- Excellent Time Management and Project Management abilities.
- Excellent written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
- Ability to handle and priorities multiple assignments, changing priorities and meet deadlines. Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
- Travel expected 20-25% of time to support clients.