Process & Formulation Scientist
Process & Formulation Scientist
Terumo Europe
Netherlands
Job Summary
As a Process and Formulation Expert, you will play a key role in developing, optimizing, and validating formulations and processes for medical devices. Working closely with cross-functional teams, you will ensure that all solutions meet regulatory standards, manufacturability requirements, and project goals. Your expertise will drive innovation from early-stage research to commercialization.
Job Responsibilities
- Product Development – Design, develop, and optimize formulations, processes, and quality controls to ensure product safety, effectiveness, and performance.
- Regulatory Compliance – Ensure adherence to FDA, MDR, and other industry regulations, preparing required technical documentation.
- Technical Documentation – Own and maintain comprehensive reports, validation plans, protocols, and specifications that support product development and regulatory submissions.
- Cross-Functional Collaboration – Lead projects with Production, Quality Assurance, and R&D teams to facilitate the transition from development to production.
- Experimental Design & Analysis – Conduct internal and external experiments, analyze data, and communicate findings for process optimization.
- Subject Matter Expertise – Act as an SME in key areas such as sterilization, biocompatibility, packaging, statistics, process validation, and formulations, supporting projects and audits.
- Equipment & Process Innovation – Lead initiatives to acquire and introduce new equipment to enhance development capabilities.
- Training & Supervision – Train R&D associates and production operators on new or updated procedures.
Profile Description
- Education: Master’s degree (or equivalent industry experience) in Pharmacy, Chemistry, Chemical Engineering, or a related field.
- Experience: 3-5 years in formulation development within the pharmaceutical or medical device industry.
- Technical Skills: Strong understanding of formulation science principles and product development processes.
- Regulatory Knowledge: Familiarity with medical device standards and regulatory requirements.
- Analytical & Problem-Solving: Skilled in data analysis, experiment design, and result interpretation.
- Communication: Strong written and verbal communication skills for collaboration and regulatory documentation.
- Project Management: Ability to manage multiple projects and meet deadlines efficiently.
- Languages: Fluent in English; Dutch is preferred.
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