Scientist, Anlaysis Review

The Scientist, Analysis Review serves as a technical reviewer responsible for ensuring analytical data generated across multiple laboratory disciplines meet applicable scientific, regulatory, and quality requirements. As part of an End-to-End (E2E) Laboratory Modernization Program, this role supports laboratory operations through independent review and verification of analytical results generated using chromatography, mass spectrometry, dissolution, aerosol, and physical testing methodologies.

The Scientist works closely with laboratory personnel, quality teams, and clients to ensure data integrity, timely reporting, and compliance with established procedures and ISO 17025 quality standards. The level of responsibility, autonomy, and technical complexity will be commensurate with experience and qualifications.

Job Responsibilities

• Perform technical review of analytical data generated from chromatography, mass spectrometry, dissolution, aerosol, and physical testing laboratories.
• Evaluate chromatographic integrations, calculations, quality control results, and supporting documentation to ensure accuracy and data integrity.
• Verify compliance with laboratory procedures, ISO 17025 requirements, and applicable regulatory expectations.
• Support investigations involving out-of-specification, out-of-trend, and atypical results.
• Participate in deviation assessments, corrective action activities, and root cause investigations.
• Review laboratory notebooks, electronic records, and LIMS entries to ensure completeness and traceability.
• Support method validation and technology transfer activities by providing technical review and data assessment.
• Collaborate with laboratory scientists, quality personnel, and clients to ensure timely delivery of high-quality analytical results.
• Identify opportunities to improve data review processes and laboratory efficiency.
• Maintain training and compliance in health, safety, environmental, and operational requirements

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time.

Critical Skills:

• Strong analytical reasoning and technical problem-solving capabilities.
• Demonstrated ability to review and interpret chromatographic and analytical data.
• Understanding of data integrity principles and quality systems.
• Familiarity with chromatography, mass spectrometry, dissolution, aerosol, and physical testing methodologies.
• Strong attention to detail and technical writing skills.
• Ability to investigate out-of-specification and atypical results.
• Excellent communication and collaboration skills

Basic Qualifications:

• Bachelor's degree in chemistry, analytical chemistry, or related scientific discipline.
• OR Associate degree with 4+ years of relevant analytical laboratory experience.
• Relevant chromatography and analytical laboratory experience commensurate with level (entry-level candidates through experienced scientists will be considered).
• Demonstrated ability to work both independently and collaboratively in a regulated laboratory environment.
• Adaptable, self-motivated, and capable of managing analytical workflows with strong attention to detail.

Preferred Qualifications:

• Experience performing analytical data review in a regulated environment.
• Familiarity with chromatography data systems and Laboratory Information Management Systems (LIMS).
• Experience supporting investigations, CAPA activities, and deviation assessments.
• Experience working in ISO 17025, GLP, GMP, or FDA-regulated laboratories.
• Experience supporting method validation and technology transfer programs.
• Knowledge of tobacco, nicotine, pharmaceutical, or consumer product testing.

Working Environment:

• Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory.
• Job pace may be fast and job completion demands may be high.
• Must be able to remain in a stationary position more than 25% of the time.
• The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite. Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
• Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).
• Specific vision abilities required by this position include without limitation, the ability to observe details at close range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
• Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer.
• Employee may be required to handle hazardous waste according to local, state, and federal regulations. Duties may include identifying, handling, generating, accumulating, storing and labeling hazardous waste.
• Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.
• May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.