Clinical Scientist Jobs

About The Position

Requirements

• Bachelor’s in MLS or related field; Master’s preferred.
• 5+ years experience in high-complexity molecular diagnostics or equivalent.
• Advanced ASCP or specialist certification strongly preferred.
• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include: Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189), Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11), Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)

Nice To Haves

• Expert-level molecular diagnostics knowledge.
• Leadership in cross-departmental initiatives and change management.
• Exceptional communication for technical and non-technical audiences.
• Ability to design, execute, and document method validations to regulatory standards.

Responsibilities

• Perform highly advanced laboratory testing procedures in alignment with established laboratory methods, study protocols, and quality requirements to support clinical research and safety study objectives.
• Prepare and handle complex or specialized samples, reagents, and materials by following detailed workflows that ensure accurate labeling, tracking, and compliance with defined handling requirements.
• Operate and maintain laboratory instruments and analytical systems by performing routine and advanced checks, calibrations, and troubleshooting steps, and reporting equipment issues to assigned personnel for follow-up.
• Record, review, and verify test data in laboratory systems with accuracy, consistency, and adherence to defined documentation and data integrity standards.
• Review assay and quality control results, identify expected and unexpected patterns, and escalate observations requiring additional analysis by senior laboratory staff.
• Perform quality control activities by running controls, documenting deviations, and contributing to the review of quality trends under established laboratory quality expectations.
• Support coordination of study activities by monitoring workflow needs, confirming the availability of materials and equipment, and completing required documentation according to defined timelines.
• Participate in verification or qualification activities related to equipment, methods, or reagent lots by following established procedures and performing assigned tasks with precision.
• Contribute to workflow refinement by identifying routine inefficiencies or procedural questions and communicating observations to senior laboratory personnel to support process clarity and consistency.
• Maintain a clean, organized, and compliant laboratory workspace by adhering to required safety, biosafety, and housekeeping practices to support ongoing regulatory readiness.

Benefits

• flexible time-off or vacation
• a 401(k) retirement plan with employer match
• medical, dental, and vision coverage
• carefully selected mindfulness programs