Scientist, Dissolution

Job Description Summary:

The Scientist, Dissolution performs dissolution testing activities that support product characterization and performance evaluations for smokeless tobacco and oral nicotine products. As part of an End-to-End (E2E) Laboratory Modernization Program, this role supports the development and assessment of regulated products through execution of dissolution methodologies and associated analytical workflows.

The Scientist is responsible for evaluating constituent release profiles using specialized dissolution systems and generating high-quality analytical data to support product development, regulatory studies, and continuous improvement initiatives. The level of responsibility, autonomy, and technical complexity will be commensurate with experience and qualifications.

Job Responsibilities

• Perform dissolution testing activities used to evaluate constituent release from smokeless tobacco and oral nicotine products.
• Operate and maintain SOTAX CE7 Smart Flow Through Cell (USP-4) dissolution systems and associated laboratory equipment.
• Prepare dissolution media, standards, reagents, and test samples in accordance with approved procedures.
• Monitor and document dissolution studies to ensure accuracy, consistency, and compliance with quality requirements.
• Review analytical data and verify calculations to ensure adherence to laboratory procedures and ISO 17025 standards.
• Support method validation, verification, and technology transfer activities involving dissolution methodologies.
• Troubleshoot instrumentation and investigate atypical analytical results and equipment-related issues.
• Maintain laboratory records and documentation in accordance with good documentation practices.
• Collaborate with analytical scientists and cross-functional teams to support product characterization and performance studies.
• Participate in continuous improvement initiatives that enhance laboratory efficiency and operational excellence.
• 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:

• Knowledge of dissolution testing methodologies, apparatus, and pharmacopeial requirements.
• Proficiency with dissolution equipment operation, calibration, and troubleshooting.
• Strong attention to detail and quality documentation practices.
• Understanding of ISO 17025 quality management systems.
• Ability to follow written SOPs and work instructions precisely.

Basic Qualifications:

• Bachelor's degree in chemistry or related scientific discipline.
• OR Associate degree with 2+ years of relevant laboratory experience.
• Relevant dissolution or 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 routine and non-routine testing tasks.

Preferred Qualifications:

• Experience operating dissolution systems and associated instrumentation.
• Familiarity with USP methodologies and product release studies.
• Experience supporting dissolution method validation and technology transfer activities.
• Experience working within ISO 17025, GLP, or GMP laboratories.
• Knowledge of tobacco, nicotine, or regulated consumer product testing.
• Experience with Laboratory Information Management Systems (LIMS) and electronic laboratory documentation systems.

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