Senior Scientist, Standards/Dissolution/Mastication

About the role

The Sr. Scientist, Standards/Dissolution/Mastication supports standards preparation, dissolution testing, and mastication (artificial saliva extraction) studies for smokeless tobacco, oral nicotine, and related regulated products within an insourced laboratory team that is part of an End-to-End (E2E) Laboratory Modernization Program. The role operates in an ISO 17025 accredited analytical production laboratory at a client site and provides advanced technical leadership and mentorship across the team.

Responsibilities

• Prepare and maintain analytical standards, calibration solutions, reagents, and reference materials for GC, GC‑MS, GC‑FID, UPLC, UHPLC, LC‑MS/MS, ICP‑MS, and dissolution methodologies, covering nicotine, minor alkaloids, menthol, VOCs, aromatic amines, benzo[a]pyrene, TSNAs, carbonyls, flavor additives, organic acids, glycidol, and other target constituents.
• Perform dissolution testing to evaluate constituent release from smokeless tobacco and oral nicotine products, including operation and maintenance of SOTAX CE7 Smart Flow Through Cell (USP‑4) and related dissolution systems.
• Conduct artificial saliva extraction (mastication) studies and associated UPLC‑based analyses (e.g., nicotine, methyl salicylate, ethyl salicylate, vanillin, glycyrrhizic acid) to characterize masticated fractions.
• Maintain inventory of reference standards, certified reference materials, reagents, and consumables, ensuring proper storage, chain‑of‑custody, and full traceability.
• Prepare dissolution media, standards, reagents, and test samples in accordance with approved procedures.
• Operate, maintain, and troubleshoot dissolution and UPLC instrumentation and associated laboratory equipment; perform routine calibration and verification of balances, pipettes, and volumetric glassware.
• Review analytical and preparation data, verify calculations, and ensure accuracy and compliance with ISO 17025 and laboratory procedures.
• Support method validation, verification, and technology transfer activities across standards preparation, dissolution, and mastication methodologies.
• Investigate atypical results and equipment‑related issues; participate in root cause analyses and corrective actions.
• Maintain laboratory records and documentation in accordance with good documentation practices and ISO 17025 requirements.
• Collaborate with analytical scientists and cross‑functional teams supporting smoke generation, aerosol collection, extraction, and chromatographic analyses.
• Mentor and train less experienced staff; coach Scientist III staff on advanced technique, method ownership, and career growth.
• Contribute to the transition from a staffing model to a Managed Service model by identifying efficiency and standardization opportunities.
• Own team‑level technical initiatives within Standards/Dissolution/Mastication and represent the team in client program reviews.
• Maintain training and compliance in health, safety, environmental, and operational requirements.

Critical Skills

• Subject‑matter expert in dissolution testing methodologies, apparatus, and pharmacopeial requirements.
• Subject‑matter expert in standards preparation supporting GC, GC‑MS, UPLC, LC‑MS/MS, ICP‑MS, and dissolution methods.
• Subject‑matter expert with UPLC instrumentation and chromatographic data analysis, including artificial saliva extraction/mastication studies.
• Precision and accuracy in gravimetric and volumetric preparation techniques.
• Strong understanding of reference material traceability and chain‑of‑custody requirements.
• Strong attention to detail and quality documentation practices.
• Understanding of ISO 17025 quality management systems.
• Ability to follow written SOPs precisely and manage multiple priorities across chromatography‑based programs.

Basic Qualifications

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, or related scientific discipline with 7+ years of relevant experience; or Master’s degree with 5+ years of relevant experience; or PhD with 2+ years of relevant experience.
• Demonstrated ability to work independently, solve complex problems, and provide technical leadership.
• Adaptable, self‑motivated, and capable of mentoring junior staff and managing complex priorities.

Preferred Qualifications

• Experience preparing standards and calibration materials for chromatographic and spectrometric analyses (GC, GC‑MS, UPLC, UHPLC, LC‑MS/MS, ICP‑MS).
• Experience operating dissolution systems and associated instrumentation; familiarity with USP methodologies and product release studies.
• Experience with UPLC instrumentation supporting nicotine and flavor constituent analyses (mastication studies).
• Experience with LIMS and electronic laboratory notebooks.
• Experience within ISO 17025, 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

• Laboratory setting requiring personal protective equipment (lab coat, safety glasses, etc.).
• Fast‑paced work with high completion demands.
• Stationary position required > 25 % of the time; occasional movement between labs, corridors, adjoining rooms, and buildings.
• Frequent bending, squatting, stretching, and reaching to operate instruments and tools.
• Occasional lifting of up to 25 lb (potential for occasional lifting of up to 50 lb).
• Vision requirements: close‑range detail, color, peripheral, depth perception, and focus adjustment.
• Occasional computer and office equipment use (calculator, copy machine, printer).
• Handling of hazardous waste per local, state, and federal regulations, including identification, generation, storage, and labeling.
• Potential exposure to extreme temperature, biological materials, and hazardous chemicals.
• May be required to complete medical clearance, respiratory protection training, and fit testing for respirator use.

Pay

The annual compensation range for this full‑time position is $65,000 to $80,000. The final base pay will be determined by internal equity, work location, and individual qualifications such as job‑related skills, experience, and relevant education or training.