Scientist, Standards/Dissolution/Mastication

About the role

The 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 the insourced laboratory team as part of an End-to-End (E2E) Laboratory Modernization Program.

Responsibilities

• Prepare and maintain analytical standards, calibration solutions, reagents, and reference materials supporting GC, GC-MS, GC-FID, UPLC, UHPLC, LC-MS/MS, ICP-MS, and dissolution methodologies.
• 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.
• Perform artificial saliva extraction (mastication) studies and associated UPLC-based analyses to characterize masticated fractions of oral nicotine and smokeless tobacco products.
• 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 and verify calculations to 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 and 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 as appropriate to level.
• Contribute to the transition from a staffing model to a Managed Service model by identifying efficiency and standardization opportunities.
• Maintain training and compliance in health, safety, environmental, and operational requirements.

Requirements

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, or related scientific discipline with 2+ years of relevant experience.
• OR Master’s degree in a related discipline with relevant laboratory experience.
• Demonstrated ability to work both independently and collaboratively in a dynamic, regulated laboratory environment.
• Adaptable, self-motivated, and capable of managing multiple concurrent tasks with moderate independence.

Preferred Qualifications

• Experience preparing standards and calibration materials supporting 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

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.

Pay

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