Staff Scientist, R&D

Position Summary

The Staff Scientist within R&D plans, designs, organizes, and conducts complex and advanced experimentation in new product development, life cycle management, and sustaining initiatives to support our Patient Blood Management (PBM) product line within Point-of-Care Hemostasis. The Staff Scientist is responsible for planning, organizing, and leading R&D activities to advance our diagnostic product portfolio, from feasibility to validation, by applying technical expertise in assay design, execution, and problem-solving, using the highest standards of quality and performance.

Key Accountabilities

• Lead and contribute to all projects (development, control, analysis) for product development, from conceptualization to commercialization.
• Lead investigations; meet specific investigation and program objectives.
• Plan, design and perform complex experiments and preparations in the laboratory; adhere to safety policies and procedures.
• Independently compile and analyze data; prepare reports and present suggestions and recommendations to management.
• Develop details and lead approach assignments with consideration of schedule, cost, reliability, simplicity, manufacturing methods and effectiveness.
• Liaise cross-functionally and with external contacts; attend and lead meetings as necessary.
• Participate in planning, leading, and defining new systems, processes and/or methods.
• Understand current reagent manufacturing processes and support improvement initiatives.
• Mentor R&D team members.
• Maintain in-depth knowledge of scientific principles; keep ahead of new industry developments.
• Lead scientific discussions both internally and externally; contribute to scientific publications in peer reviewed journals.
• Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures, and processes.
• Provide advanced technical support to Manufacturing, primarily through analytical testing in support of Validation and Verification activities.
• Identify opportunities for continuous improvement initiatives for assay development processes.
• Other duties as assigned.

Minimum Knowledge & Experience

• Bachelor’s degree (required) and completion of a Ph.D. degree (preferred) in a scientific discipline, or equivalent.
• Minimum of seven (7) years previous medical/in vitro diagnostic research experience required.
• Whole blood hemostasis experience preferred.
• Demonstrated experience in assay development in the IVD industry.
• Exceptional investigative ability is a must.

Skills & Capabilities

• Must possess an understanding of physical, chemical, and stabilization of proteins and enzymes with expertise in designing and conducting relevant experiments required.
• Superior technical writing and documentation, communication, interpersonal, and presentation skills are essential.
• Experience leveraging Design of Experiments (DOE) and Design for Six Sigma (DFSS) tools and principles in the product development process.
• Understanding of regulatory requirements and quality management systems in the diagnostic industry.
• Computer literacy required; knowledge of basic software tools (Excel, Word, PowerPoint, Teams).
• Knowledge of SAP and statistical software packages preferred.
• Knowledge and/or experience with lyophilization preferred.
• Experience with difficult sample matrices, particularly whole blood and plasma.
• Understanding of program objectives; ability to meet objectives.
• Ability to design and conduct experiments; ability to analyze and document results, using good documentation practices for internal records and regulatory submissions.
• Teamwork and ability to work independently.
• Investigative ability with superior analytical skills is critical.
• Scientific knowledge and application.

Travel Requirements

5% travel may be required.