HiTech Health focuses on enabling healthcare companies to develop, launch and supply products to the market. 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 globally from the development to the launch and supply of products.
This is an exciting role for a dynamic and determined individual to join a growing organisation, to work as a Project Manager supporting a diverse range of clients as they progress products from development through to commercial manufacturing and supply to patients. The candidate will lead projects, using their experience and expertise, to manage the development of new drug products and/or devices, as well playing a key role in the growth of HiTech Health.
- Effectively lead projects, particularly in the area of biopharmaceuticals, from initial client briefing through to execution and completion within a highly regulated environment.
- Ensure that project tasks are controlled and executed, as well as project goals are delivered on time, within budget, to specification and meeting the highest standards of quality.
- Participate in cross-functional projects for the development and scale-up of products, ensuring compliance with EU and US regulations.
- Communicate progress to business and technical stakeholders throughout projects. Reporting directly to the Managing Director on a regular basis to ensure client’s goals are being efficiently met in line with quality and compliance standards.
- Work closely with suppliers and subcontractors in satisfying our clients’ expectations.
- Lead trouble-shooting activities and provide sustainable solutions for root cause processing problems.
- Optimally use innovative business processes to support the launch and supply of products to patients, e.g. change control, deviations, investigations, etc.
- Monitor and report the project’s progress, identify and control any risks to the project’s schedule or commercial objectives.
- An Upper Second Class Honours Bachelor of Engineering or Science is required at minimum (preferably Biotechnology, Biochemical or Biomedical Engineering).
- Experience with new product development, product transfer/scale-up and introduction is expected.
- Minimum 8 years of experience in the Biotechnology industry in product development/new product introduction roles.
- Excellent working knowledge of Drug Substance, Drug Product processes and Cell Manufacturing.
- Understanding of quality systems, FDA and EU regulations, cGMP and ICH guidelines.
- Experience in people management is favourable. Ability to critically assess situations and make strategic decisions.
- Excellent Time Management and Project Management abilities. A Project Management Certificate is desirable.
- Outstanding written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
- Manage and prioritise 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.
- Willingness to support and contribute to other business areas as requested.
- Travel expected 10-15% of time to support clients.