Scientist, Standards

Job Description Summary:

The Scientist, Standards will prepare and maintain analytical standards, calibration materials, reagents, and reference solutions within the insourced laboratory team as part of an End-to-End (E2E) Laboratory Modernization Program. This role supports chromatographic, aerosol, dissolution, and physical testing laboratories by ensuring the accuracy, traceability, and integrity of standards used for analytical testing at a client site. Activities include preparation of standards supporting GC, GC-MS, UPLC, LC-MS/MS, ICP-MS, dissolution, smoke, and aerosol testing methods. The level of responsibility, autonomy, and technical complexity will be commensurate with experience and qualifications.

Job Responsibilities

• Prepare and maintain analytical standards, calibration solutions, reagents, and working solutions supporting physical testing, smoke, aerosol, dissolution, and chromatography-based methods.
• Prepare standards and calibration materials supporting analyses of nicotine, minor alkaloids, menthol, volatile organic compounds (VOCs), aromatic amines, benzo[a]pyrene, TSNAs, carbonyls, flavor additives, nicotine degradants, organic acids, glycidol, primary constituents, and elemental analyses.
• Support standard preparation activities associated with GC, GC-MS, GC-FID, UPLC, UHPLC, LC-MS/MS, ICP-MS, and dissolution methodologies.
• Maintain inventory of reference standards, certified reference materials, reagents, solvents, and consumables, ensuring proper storage conditions and full traceability.
• Ensure chain-of-custody and traceability requirements are maintained for all reference materials and analytical reagents.
• Document standards preparation activities and maintain records in laboratory notebooks and LIMS in accordance with good documentation practices.
• Perform routine calibration and verification of balances, pipettes, volumetric glassware, and associated laboratory equipment.
• Support method validation, method transfer, and verification activities involving standards preparation procedures.
• Review preparation records and analytical documentation to ensure compliance with ISO 17025 quality requirements and data integrity principles.
• Investigate preparation issues and support root cause analysis activities as appropriate to level.
• Collaborate with analytical scientists supporting smoke generation, aerosol collection, dissolution testing, physical characterization, extraction, and chromatographic analyses.
• Mentor and train less experienced staff as appropriate to level.
• Contributes to the transition from a staffing model to a Managed Service model by identifying opportunities to improve efficiency, standardization, and laboratory effectiveness.
• Maintain training and compliance in areas of health and safety, security, environmental and operational aspects of daily activities in the working environment.

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

Critical Skills:

• Precision and accuracy in gravimetric and volumetric preparation techniques.
• Strong understanding of reference material traceability and chain-of-custody requirements.
• Knowledge of standards preparation supporting GC, GC-MS, UPLC, LC-MS/MS, ICP-MS, and dissolution methods.
• Strong attention to detail and documentation practices.
• Knowledge of analytical balances, pipettes, and volumetric equipment verification procedures.
• Familiarity with ISO 17025 quality management systems and data integrity requirements.
• Strong organizational and problem-solving skills.
• Ability to prioritize work across multiple analytical programs.

Basic Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
• OR Associate degree with 2+ years of relevant laboratory experience.
• Relevant standards preparation or analytical laboratory experience commensurate with level (entry-level candidates through experienced scientists will be considered).
• Demonstrated ability to work independently and collaboratively in a regulated laboratory environment.
• Adaptable, self-motivated, and capable of performing precise, detail-oriented laboratory work.
• Strong written and verbal communication skills.

Preferred Qualifications:

• Experience preparing standards and calibration materials supporting chromatographic and spectrometric analyses.
• Familiarity with GC, GC-MS, UPLC, UHPLC, LC-MS/MS, and ICP-MS instrumentation.
• Experience with Laboratory Information Management Systems (LIMS) and electronic laboratory notebooks.
• Experience working within ISO 17025-accredited, GLP, or GMP laboratory environments.
• Knowledge of tobacco, nicotine, inhalable, aerosol, or consumer product testing requirements.
• Experience supporting method validation, method transfer, and continuous improvement initiatives.

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.