The continued growth in the development of cell and gene therapies (CGTs) has led to an exponential increase in the workload of the organisations involved. As ClinicalTrials.gov. indicates, there will be more than 1,000 ongoing clinical trials for CGTs registered in...
Biopharmaceutical Project Manager
Biopharmaceutical Project Manager
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 Project Manager. The role will involve supporting a diverse range of clients as they progress products from development through to supply to patients. The candidate will lead projects within a multi-disciplinary team environment.
- Effectively lead projects, particularly in the area of advanced medicines, 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.
- 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.
- 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.
- Optimally use innovative business processes 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 3 years of experience in a life sciences industry.
- Excellent working knowledge of Drug Substance and Drug Product processes.
- 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, 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.
- Travel to support clients may be required while meeting Covid-19 regulations.
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 firstname.lastname@example.org with your CV and referencing the job role in the subject line.
Location: Discussed upon interview
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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