Research Scientist II - Molecular Diagnostics & Validation

Fives DyAG Corp.; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Fives DyAG Corp. in La Jolla, CA is seeking a Research Scientist II for a 3+ month contract to lead verification and validation studies for molecular test products within CAP/CLIA clinical laboratories and regulatory submissions.

You will design studies with biostatistics, bioinformatics, regulatory, quality, and clinical lab operations, mentor junior researchers, and present results to leadership. Travel up to 5% may be required. This role aligns with our quality standards and mission.

Qualifications

• Experience with lab operations and lab management responsibilities.
• PhD in a field related to essential duties; or Master's degree in a related field and 4 years of relevant experience in lieu of PhD; or Bachelor's degree in a related field and 6 years of relevant experience in lieu of PhD.
• Demonstrated experience in designing and executing complex experiments, performing quantitative data analysis, and interpreting results to guide next-phase studies.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.

Responsibilities

• Lead select verification and validation studies to support molecular test product launch in CAP/CLIA clinical laboratory and regulatory submission, including but not limited to: PMA (Pre-market approval) and IDE (Investigational Device Exemption)
• Lead cross-functional study design discussion for the study you own, working closely with multiple departments such as biostatistics, bioinformatics, regulatory, medical director, quality and clinical lab operations
• Mentor and provide technical guidance to junior research associates
• Present experimental results and defend scientific findings at data, group, and project team meetings
• Integrates project results into broader research objectives; prepares and reviews technical reports and presents findings to project teams and leadership.
• Contributes to protocol/procedure development, process improvement, and relevant regulatory compliance and quality standards.
• Effectively collaborates with multidisciplinary teams across projects, ensuring alignment with business and scientific goals.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Ability to lift up to 25 pounds within the typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 50% of a typical working day.
• Ability to complete fine finger manipulation (e.g., picking, pinching, etc.) and twisting at wrist motions 50% of a typical working day.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Job description

Fives DyAG Corp. in La Jolla, CA is seeking a Research Scientist II for a 3+ month contract to lead verification and validation studies for molecular test products within CAP/CLIA clinical laboratories and regulatory submissions.

You will design studies with biostatistics, bioinformatics, regulatory, quality, and clinical lab operations, mentor junior researchers, and present results to leadership. Travel up to 5% may be required. This role aligns with our quality standards and mission.