Overview In this role you perform analytical chemistry testing to support raw materials, in-process, finished goods, and stability programs under cGMP, ensuring quality and regulatory compliance. You will develop expertise in analytical testing methods, instrumentation, and QC systems within regulated pharmaceutical and medical device environments. You work with cross-functional teams to develop, transfer, qualify, and validate methods, and you contribute to data integrity and continuous improvement initiatives.
Compensation / Benefits- discretionary bonus program
- comprehensive healthcare benefits
- health savings account
- 401(k) plan with up to 5% company match
- employee stock purchase plan at a 15% discount
- accrued paid time off
Responsibilities- Perform analytical testing of incoming materials per USP, EP, ACS Reagent Index, and internal methods
- Execute assays for in-process, release, stability, Engineering, and R&D samples using chromatographic, spectroscopic, and wet chemistry techniques
- Operate and maintain lab instruments (HPLC, GC, GC/MS, UV/Vis, FTIR, pH meters, osmometers, TOC analyzers, conductivity meters, viscometers, titration systems)
- Conduct Karl Fischer moisture analysis, headspace, titrations, viscosity, and compendial identification testing
- Complete documentation and data recording in GDP and cGMP
- Review notebooks, verify results, and support data integrity and compliance
- Collaborate with R&D and cross-functional teams to support method development, transfer, qualification, and validation
- Research, optimize, qualify, and validate analytical methods per industry best practices
- Report deviations/nonconformances, participate in investigations, support corrective actions
- Maintain training compliance for procedures, techniques, and safety
- Perform routine maintenance of lab equipment and instrumentation
- Support continuous improvement initiatives and additional projects as assigned
Key requirements- Bachelor's degree in Chemistry, Physical Science, or related scientific discipline; equivalent experience may be considered
- 2-5 years of analytical testing experience in FDA-regulated pharmaceutical or medical device industries
- Demonstrated knowledge of GMP and ISO regulatory requirements
- Hands-on experience with HPLC and GC analyses, including method development and validation
- Experience using UV/Vis, FTIR, pH meters, and osmometers
- Proficiency in wet chemistry techniques including titrations and compendial identification testing
- Strong documentation, organizational, and problem-solving skills
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment
- Willingness to support varying work schedules
- Attention to detail
- Strong organizational skills
- Problem-solving abilities
- HPLC
- GC
- GC/MS
