Scientist / Sr. Scientist, Analytical Chemistry

Role Summary

Role: Scientist / Sr. Scientist, Analytical Chemistry. Develops and executes instrumental methods of analysis for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials to develop assays based on new and existing methodologies. Responsible for coordinating and supporting day-to-day operations in an Analytical Development (AD) GMP lab, focusing on GMP laboratory workflows. Schedules instrument calibrations, maintenance and qualification activities; ensures compliance with GMP and supports continuous improvement of lab processes and equipment readiness.

Responsibilities

• Develops and executes instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials
• Follows established test methods, procedures, and pharmacopeia chapters to generate data for strategic decision making
• Serve as the primary point of contact for all instrument-related activities and maintain equipment inventory, calibration and service records in compliance with GMP
• Coordinates vendor service calls for repair and maintenance of laboratory instruments; perform routine maintenance and maintain records of instrument service and repairs
• Assist investigations for out of specification, out of trend, and/or anomalous results with supervision
• Participates in internal and external audits as SME for lab instrumentation
• Support training of GMP lab staff on procedures, GMP requirements and safety protocols
• Coordinate daily lab operations
• Maintains complete and accurate records of laboratory work in conformance with SOPs and training
• Provides detailed reviews of peer generated data and data from contracted service providers
• Maintains inventory of GMP laboratory consumables and clean glassware
• Performs other duties as assigned

Qualifications

• BS/BA degree in chemistry or closely related field and 2+ years of pharmaceutical industry experience in an R&D/QC setting, including conducting HPLC analysis and troubleshooting, evaluating analytical data and drawing meaningful conclusions
• MS/MA degree in chemistry or closely related field preferred and some similar industry experience
• PhD in chemistry or closely related field a plus
• Proficient in MS-Excel, MS-Word and data systems for computer-controlled instrumentation
• Practical working knowledge of conducting HPLC analysis and troubleshooting
• Experience evaluating analytical data and drawing meaningful conclusions
• Knowledge of cGMP expectations for laboratory records and quality systems
• Ability to provide ideas for process improvements
• Able to identify anomalies in data and issues in experiments/processes
• Ability to think beyond the technical process and consider broader scientific goals
• Strong knowledge of one scientific discipline; good knowledge of scientific principles, methods and techniques
• Experience with various laboratory equipment/tools
• Ability to work in a team to meet goals within timelines
• Strong computer skills; good communication, problem-solving, analytical thinking
• Detail oriented; ability to meet deadlines; good project management skills

Skills

• Instrumental analysis (HPLC, GC, MS, FTIR, DSC, TGA)
• Laboratory operations and GMP compliance
• Data analysis and interpretation
• Laboratory instrumentation maintenance and calibration
• Technical troubleshooting and troubleshooting documentation
• Team collaboration and training
• Documentation management (SOPs, records)

Education

• BS/BA in chemistry or closely related field required; MS/MA preferred; PhD a plus