Research Scientist II

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

Title: Research Scientist II
Location: La Jolla CA 92037
Duration: 3+ Months contract
Shift Details: 09 AM - 05:00 PM

Description:

DO WORK THAT MATTERS

diverse ideas, perspectives, and expertise allow us to create life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, it offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

RESPONSIBILITIES

Include, but are not limited to, the following:

• 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.

Minimum 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.

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