Senior Scientist-IVD Test Development

Job Description

Job Overview

We are seeking a highly skilled Senior Scientist with expertise in in vitro diagnostic (IVD) assay development to lead complex research projects and drive scientific innovation. The successful candidate will manage product Validation & Verification studies supporting PMA, 510K, and IVDR approval, working in a regulated environment under design control. This role involves project timeline management, data interpretation, and mentorship of junior scientists. The position may also require handling human biological specimens, including blood, plasma, urine, and other bodily fluids, in compliance with all safety regulations and company policies.

Essential Duties & Responsibilities

• Lead project studies supporting regulatory filings, working on multiple unrelated projects simultaneously
• Train and mentor junior scientists, fostering a culture of scientific excellence
• Execute and document product development work under design control and the company’s quality management systems, policies, and procedures
• Develop and optimize study protocols, ensuring scientific rigor and compliance with CLSI guidelines and regulatory agency requirements
• Perform complex statistical analyses independently or in coordination with statisticians
• Interpret experimental results, draw conclusions, and define next steps to achieve project objectives
• Ensure analyses and result interpretation are accurate and appropriate to support internal reports regulatory submissions, and scientific publications
• Prepare clear, concise, and professional study reports to support regulatory submissions
• Develop and deliver data-driven presentations for internal and external stakeholders
• Create presentations to effectively communicate key research findings and project status
• Lead technical discussions and project meetings, ensuring alignment with strategic goals
• Ensure compliance with all safety and company policies, including biosafety and hazardous material handling protocols
• Perform all other duties as assigned

Qualifications

• Education & Experience:

• Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 16-20 years of relevant experience

• Master’s degree with 10-15 years of experience

• Ph.D. with 7-12 years of experience

• Technical Skills:

• Extensive technical and managerial expertise in IVD product development

• Experienced at creating protocols and reports suitable for regulatory submission

• Strong understanding of FDA and global regulatory requirements

Experience with statistical analysis software (Analyze-It, JMP)

Commercial IVD product development experience preferred

• Leadership & Analytical Skills:

• Demonstrated ability to lead research teams and manage multiple projects effectively

• Strong data analysis and statistical interpretation skills

• Ability to troubleshoot complex technical issues and drive problem-solving initiatives

• Communication & Collaboration:

• Proven ability to develop high-impact scientific reports, publications, and presentations

• Excellent verbal and written communication skills, with experience presenting to diverse audiences

• Strong interpersonal skills for mentorship and cross-functional collaboration