Biopharmaceutical Product Development Scientist/Engineer

Biopharmaceutical Product Development Scientist/Engineer

Ireland | Permanent full-time role & flexible working conditions

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.

We have an opportunity for a highly motivated and flexible individual to join a growing organisation, to work as a Product Development Scientist/Engineer supporting a diverse range of clients as they progress products from development through to commercial manufacturing and supply to patients. The candidate will lead and support projects including the development, launch and supply of new products across international markets.

Responsibilities:

• 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.
• 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.
• 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.
• Monitor and report the project’s progress, identify and control any risks to the project’s schedule or commercial objectives.

Essential Requirements:

• A degree in an Engineering or Science area is required at minimum (preferably Biotechnology, Biochemical or Biomedical Engineering).
• Experience with new product development, product transfer/scale-up and introduction is expected.
• Minimum 5 years of experience in the Biotechnology industry in product development/new product introduction roles.
• 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.
• Manage and prioritise multiple assignments within a fast paced environment.
• 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 9-5.30 daily. The nature of the work may require flexibility in working times.

Location: Negotiable