Job Description

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.

• These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.
  

Required Qualifications:

• 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)

Preferred Qualifications:

• 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.

Physical Demands and Working Environment:

• Operate in a CLIA- and CAP-accredited clinical laboratory with routine exposure to biohazardous materials and chemicals, requiring full PPE and biosafety compliance.

• Physically active environment with prolonged standing, repetitive tasks, and frequent instrument interaction. Ability to lift reagents or supplies (~25–30 lbs) occasionally.

• Flexible scheduling needed to support GRAIL’s testing operations—including early/late shifts and potential weekend/on-call coverage.

• Occasional travel may be required for training, labs benchmarking, or cross-site support.