TEMP - Scientist, Analytical Chemistry, CMC

Role Summary

TEMP - Scientist, Analytical Chemistry, CMC. Independently conduct laboratory experiments in support of Chemical Development projects. Provide analytical support to late-stage programs, ensuring methods for regulatory starting materials and intermediates are ready for validation. Collaborate with teams in large open analytical labs and document work in accordance with guidelines.

Responsibilities

• Develops and executes instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) for development compounds, drug substances, raw materials, intermediates, drug products, and packaging materials
• Follows established test methods, procedures, and pharmacopeia chapters to generate data for strategic decisions
• Plans and executes in-house stability studies for drug substances, intermediates, and prototype drug products (with supervision)
• Assists/leads development of analytical methods and investigations for out-of-specification, out-of-trend, and anomalous results (with supervision)
• Collaborates on cross-functional studies for chemical development and formulation development (with supervision)
• Recognizes and responds to unexpected or anomalous observations in all activities
• Maintains complete and accurate records of laboratory work per SOPs and training
• Provides detailed reviews of peer-generated data and data from contracted service providers
• Maintains inventory of laboratory consumables and glassware
• Coordinates vendor service calls for repair and maintenance of laboratory instruments; maintains records of instrument service and repairs
• Performs other duties as assigned

Qualifications

• BS/BA in chemistry or closely related field and 2+ years of pharmaceutical industry experience in an R&D/QC setting, including HPLC analysis and troubleshooting
• MS/MA in chemistry or closely related field preferred with similar industry experience
• PhD in chemistry or closely related field and relevant experience a plus
• Proficient with MS Excel and MS Word; familiarity with data systems for computer-controlled instrumentation
• Practical working knowledge of HPLC analysis and troubleshooting
• Experience evaluating analytical data and drawing meaningful conclusions
• Knowledge of cGMP expectations for laboratory records and quality systems
• Ability to propose process improvements; recognize anomalies in data
• Ability to think beyond technical process and consider broader scientific goals
• Strong knowledge in at least one scientific discipline; solid understanding of scientific principles, methods, and techniques
• Experience with a variety of laboratory equipment/tools; strong computer skills
• Good communication, problem-solving, and analytical thinking skills
• Detail oriented; ability to meet deadlines; good project management skills

Education

• As listed in Qualifications above

Additional Requirements

• None beyond qualifications listed