Sr Scientist, In Vitro Diagnostics (IVD)

Senior Scientist - IVD Assay Development

The client is seeking a highly skilled Senior Scientist with expertise in in vitro diagnostic (IVD) assay development to lead complex research initiatives and drive scientific innovation. This individual will be responsible for managing product Validation & Verification studies in support of PMA, 510K, and IVDR regulatory approvals within a design-controlled, regulated environment. Responsibilities include overseeing project timelines, interpreting complex data, and mentoring junior team members. The role may involve working with human biological specimens (e.g., blood, plasma, urine) in compliance with safety regulations and internal protocols.

Essential Duties & Responsibilities

• Lead project studies supporting regulatory filings across multiple unrelated projects

• Mentor and train junior scientists, promoting a culture of scientific rigor

• Execute and document development work under design control and quality management systems

• Develop and optimize study protocols aligned with CLSI guidelines and regulatory standards

• Perform complex statistical analyses independently or in collaboration with statisticians

• Interpret data, draw conclusions, and define actionable next steps

• Ensure accuracy and appropriateness of analyses to support internal reports, regulatory submissions, and publications

• Prepare professional, concise study reports for regulatory review

• Present research findings and project updates to internal and external stakeholders

• Lead technical discussions and cross-functional project meetings

• Maintain full compliance with safety protocols and company policies, including biosafety standards

• Perform other related duties as assigned
  
  

Qualifications

Statistical Analysis Tools:

• Experience with tools such as Analyze-It and JMP

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:

• Deep technical and managerial experience in IVD product development

• Skilled in designing protocols and reports for regulatory submission

• Strong understanding of FDA and global regulatory frameworks

• Experience in commercial IVD product development is preferred

Leadership & Analytical Skills:

• Proven ability to lead teams and manage multiple concurrent projects

• Strong data analysis and statistical interpretation skills

• Effective at troubleshooting and driving resolution of complex technical challenges

Communication & Collaboration:

• Capable of producing high-quality reports, publications, and presentations

• Excellent communication skills across diverse technical and non-technical audiences

• Strong team player with demonstrated mentorship and cross-functional collaboration skills