Job Title: Chemist III
Job Description
The Chemist III applies advanced analytical chemistry techniques to support pharmaceutical research and development, with a focus on complex impurity profiling and characterization of drug products and peptides in a regulated environment. This role plans and executes laboratory experiments, develops and troubleshoots analytical methods, and delivers high-quality, GxP-compliant data that advances emerging cGMP manufacturing processes. The Chemist III works independently, interprets complex data, and communicates findings clearly to interdisciplinary teams.
Responsibilities
- Apply analytical separation and detection techniques to perform complex impurity profiling of pharmaceutical products and support understanding of emerging cGMP manufacturing processes.
- Plan, execute, and complete assigned laboratory tasks using standard procedures and a solid technical understanding of analytical techniques.
- Independently generate precise, reliable, and reproducible analytical data in a timely manner while meeting regulatory and GxP requirements.
- Document all experiments, methods, and results accurately and comprehensively in accordance with regulatory and GxP documentation standards.
- Demonstrate strong experimental precision and data interpretation skills, and apply core analytical chemistry principles to solve complex problems.
- Develop protocols for more complex tests or experiments, including assays with less-defined parameters, and optimize methods for robustness and reliability.
- Independently develop and troubleshoot analytical methods, particularly chromatography-based methods such as HPLC and GC.
- Apply mass spectrometry and LC/MS techniques to support characterization, impurity profiling, and structural elucidation of small molecules and peptides.
- Support analytical method development and characterization activities for pharmaceutical R&D programs, including synthetic molecule and peptide development.
- Ensure all work complies with safety, GxP, GMP, and GLP expectations when performing laboratory tasks and handling materials.
- Ensure timely delivery of high-quality, GxP-compliant analytical data and contribute to stability studies, trending analysis, and impurity profiling as needed.
- Use computer skills, including word processing, spreadsheets, and instrument-related systems, to manage data, reports, and laboratory records.
- Operate and maintain analytical instruments such as HPLC, GC, LC/MS, and chromatography data systems, ensuring proper calibration and performance.
- Present experimental findings, data interpretations, and conclusions to larger audiences, including interdisciplinary scientists and engineers.
- Collaborate effectively with cross-functional teams, providing analytical expertise and clear communication to support project goals.
Essential Skills
- Strong technical experience in analytical chemistry with excellent analytical problem-solving skills.
- Proven ability to independently develop and troubleshoot analytical methods for complex pharmaceutical samples.
- Hands-on experience with chromatography method development and analysis, including HPLC and GC.
- Fundamental understanding and practical experience with mass spectrometry and LC/MS-based analytical techniques.
- Experience generating, interpreting, and presenting complex analytical data for pharmaceutical R&D programs.
- High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.
- Practical knowledge of organic structure, functional groups, and chemistry as applied to small-molecule and/or peptide analytical analysis.
- Experience with modern spectroscopic and analytical techniques relevant to small-molecule and peptide characterization.
- Familiarity with GMP and GLP principles and experience working in a regulated laboratory environment.
- Strong documentation skills and ability to maintain GxP-compliant records and reports.
- Experienced use of analytical instruments including HPLC, GC, LC/MS, and chromatography data systems such as Empower, OpenLab, or Chromeleon.
- Bachelor's, Master's, or Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Chemical Engineering, Medical Technology, Biology, or a related scientific discipline.
- Minimum 5+ years of analytical chemistry experience in industry and/or academia.
- For Bachelor's or Master's degree holders, at least 5+ years of pharmaceutical industry laboratory experience.
- For Ph.D. candidates, at least 5+ years of combined academic research and/or industry experience.
- Demonstrated ability to su