Scientist, Standards/Dissolution/Mastication
About The Position
When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services. 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. Staff on this team typically concentrate in one of these three areas based on assignment, while collaborating closely across all three given their shared chromatographic and quality workflows. This role operates within an ISO 17025 accredited analytical production laboratory at a client site. The Scientist performs the activities above with moderate independence, applying developing technical judgment across routine and moderately complex tasks.
Requirements
- Knowledge of dissolution testing methodologies, apparatus, and pharmacopeial requirements.
- Knowledge of standards preparation supporting GC, GC-MS, UPLC, LC-MS/MS, ICP-MS, and dissolution methods.
- Experience 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.
- 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.
Nice To Haves
- 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.
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, including standards for 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.
- Perform artificial saliva extraction (mastication) studies and associated UPLC-based analyses (e.g., nicotine, methyl salicylate, ethyl salicylate, vanillin, glycyrrhizic acid) 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.
- Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.
Benefits
- health_insurance
- dental_insurance
- vision_insurance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
