Temp - Scientist, Analytical Development, CMC

Role Summary

Temp - Scientist, Analytical Development, CMC

Responsibilities

• Develops and executes instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) of analyses for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials
• Accurately follows established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making
• With supervision, plans and executes in-house stability studies for drug substances, intermediates, and prototype drug products
• With supervision and as appropriate, assists/leads the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results
• With supervision, collaboratively plans and executes cross functional studies for chemical development and formulation development
• Recognizes and responds to unexpected or anomalous observations in all activities
• Maintains complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training
• Provides detailed reviews of peer generated data as well as that generated from contracted service providers
• Maintains the inventory of laboratory consumables and clean glassware
• Coordinates vendors service calls for repair and maintenance of laboratory instruments, with training perform routine maintenance of laboratory instrumentation, maintains complete and accurate records of instrument service and repairs in conformance with company SOPs and policies
• 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 OR
• MS/MA degree in chemistry or closely related field preferred and some similar industry experience noted above OR
• PhD in chemistry or closely related field and some industry or relevant experience a plus
• Proficient in using MS-Excel, MS-Word as well as data systems for computer-controlled instrumentation
• Practical working knowledge of conducting HPLC analysis and troubleshooting
• Some expertise in evaluating analytical data and drawing meaningful conclusions
• Knowledge of cGMP expectations for laboratory records and quality systems
• Ability to provide ideas for process improvements
• Recognizes fundamental anomalies in data points and identifies issues in experiments / processes
• Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals
• Strong knowledge of one scientific discipline
• Good knowledge of scientific principles, methods and techniques
• Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools
• Ability to work as part of a team of individuals to meet goals, tasks in a timeline driven setting
• Strong computer skills
• Good communications, problem-solving, analytical thinking skills
• Detail oriented
• Ability to meet deadlines
• Good project management skills