Ireland, 12th Feb 2024: Hitech Health, a Contract Development and Manufacturing Organisation (CDMO) for advanced therapies, has opened an additional facility in County Galway, Ireland. The new high-specification manufacturing centre is equipped with state-of-the-art...
Biopharmaceutical Product Development Scientist/Engineer
Ireland | Permanent full-time role & flexible working conditions
HiTech Health is a Contract Development and Manufacturing Organisation (CDMO) for advanced medicines including cell and gene therapies. 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.
We have an opportunity for a highly motivated team-player to join our growing organisation, working as a Biopharmaceutical Product Development Scientist/Engineer. The role will involve supporting a diverse range of clients as they progress new medicines from development through to supply of these new therapies to patients. The focus area of the role is the CMC development and manufacture of these new medicines. Hitech Health have good business systems to support the successful candidate in the role and all appropriate training will be provided.
The candidate will lead projects within a multi-disciplinary team environment.
- Effectively lead projects, particularly in the area of advanced medicines (Cell and Gene Therapies), from initial client briefing through clinical trials and product launch support.
- Project manage and communicate progress of projects to business and technical stakeholders.
- 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 and regulatory.
- Supporting clients with supply chain and logistics requirements in line with Good Distribution Practice (GDP) guidelines.
- Participate in cross-functional projects, working closely with other departments (QA and Regulatory etc.) for the development and scale-up of products, ensuring compliance with EU and US regulations.
- Reporting directly to the Managing Director on a regular basis to ensure client’s goals are being efficiently met.
- Optimally use innovative business processes and tools to support the launch and supply of products to patients.
- Monitor and report the project’s progress, identify and control any risks to the project’s schedule or commercial objectives.
- A degree in an Engineering or Science area is required at minimum (preferably Biotechnology, Bio/Chemical or Biomedical Engineering).
- Minimum 5 years of experience in the biopharmaceutical industry.
- Excellent working knowledge of Drug Substance and Drug Product manufacturing processes.
- 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 but not essential.
- Outstanding written, verbal and interpersonal communication skills, presentation skills and the ability to effectively interact cross functionally.
- 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.
- Understanding of quality systems, FDA and EU regulations, cGMP and ICH guidelines.
- Travel to support clients may be required.
Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.
Working hours: Working hours will be 9 AM-5.30 PM daily. The nature of the work may require flexibility in working times.
Start date: On completion of recruitment process.
To Apply: Please email your CV to email@example.com with your CV and referencing the job role in the subject line.
Location: Discussed upon interview. Hitech Health provides a flexible working environment.
We reserve the right to re-advertise or extend the closing date for this job post.
HiTech Health is an equal opportunities employer.
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