R&D Project Leader

Diasorin•Stillwater, MN

About The Position

Obsessed by Science. Entrepreneurial by Nature. United by Purpose. Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions. As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios. When you join Diasorin, you are not just filling a role. You are helping build what comes next. Why Join Diasorin Build What Matters Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide. Innovate with Agility at a Global Scale Work in an entrepreneurial environment that enables speed, collaboration, and global impact. Grow in a People-Centered Culture Thrive in a culture that values accountability, inclusion, and continuous development. Job Scope The Product Development Project Leader is responsible for leading the development, validation, and lifecycle support of automated immunodiagnostic products. This role combines deep technical expertise with people leadership and cross‑functional collaboration to deliver high‑quality diagnostic solutions within regulated design control environments.

Requirements

BS in a relevant science discipline (e.g. Biology, Biochemistry) required
PhD: 5+ years required
MS: 7+ years required
BS: 10+ years required
Experience in the medical device or diagnostics industry required
Demonstrated experience in immunodiagnostic assay development required
Strong understanding of immunology, protein chemistry, and automated immunoassay systems.
Proven ability to lead technical troubleshooting and complex problem-solving efforts.
Solid knowledge of Design Control and regulated product development processes.
Excellent written and verbal communication skills, including technical presentations.
Proficiency with Microsoft Word, Excel, PowerPoint; familiarity with collaborative tools (e.g., Microsoft 360).
Ability to manage multiple projects simultaneously while maintaining high quality standards.

Nice To Haves

PhD or MS in a relevant science discipline (e.g. Biology, Biochemistry) preferred
People leadership or supervisory experience preferred

Responsibilities

Lead the development and validation of immunodiagnostic assays, from concept through design validation.
Design, execute, and interpret experiments to support assay design, performance, and manufacturability.
Provide hands-on technical leadership, including root cause analysis and troubleshooting of complex assay issues.
Apply strong scientific judgment to connect assay performance with underlying biology, chemistry, and clinical use.
Generate innovative ideas for new products, product improvements, and process enhancements.
Own and manage project documentation and deliverables in compliance with Design Control, QSR, ISO, and GMP requirements.
Plan, execute, and track development milestones to meet defined timelines and quality objectives.
Maintain complete and accurate technical records using laboratory notebooks and electronic systems.
Prepare technical reports, presentations, and data summaries for internal and external stakeholders.
Serve as a core team member working closely with Quality, Regulatory, Manufacturing, Marketing, and Operations.
Support existing commercial products, including investigation of field issues, customer complaints, and continuous improvement initiatives.
Represent Product Development in cross-functional discussions and present technical information in formal settings.
Contribute to external scientific publications, posters, and presentations as appropriate.
Lead, mentor, and develop a team of 2–3 Scientists, fostering a motivated, accountable, and collaborative environment.
Provide technical guidance, coaching, and performance feedback to team members.
Promote ethical leadership, open communication, and a strong culture of scientific rigor and teamwork.
Train and support internal stakeholders on new assays, methods, and tools.