Research Associate

The Analytical R&D Research Associate I:

Working somewhat independently, provides analytical support of new formulation development samples of Solid Oral Dosage forms. The primary focus will be to support the physical (particle size, viscosity, etc.) and chemical (dissolution, assay, content uniformity, related compounds etc.) characterization of internally developed SOD formulations and Reference Listed Drug products. and formulation testing, accurately and concisely documents data, and reports results.

The Analytical R&D Research Associate I reports to the Manager, Analytical R&D.

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  Perform routine sample analysis requiring general laboratory skills such as weighing, pipetting, titration, and basic operation of laboratory instrumentation
• Perform various analytical testing, including by Dissolution, HPLC, UV and GC following established testing procedures for raw materials, finished products, and/or stability samples
• Comprehend and follow approved test methods accurately in the performance of sample analysis to ensure adherence to “Right-the First Time” philosophy
• Perform analysis with a practical understanding of the test procedure and instrument operation
• Use available software to control instrumentation, collect data, process and calculate results, and report results
• Perform testing to evaluate physical characteristics of raw materials and finished products
• With input from laboratory management, organize work schedule to complete assigned tasks efficiently and on schedule
• Maintain accurate record of analysis, following all company good documentation practices.
• Perform job functions in a safe manner consistent with site safety practices and regulatory (e.g. – OSHA) requirements
• Prepare test solutions, reagents, and samples used in analysis
• Other duties as assigned

• BS or MS in Chemistry, Biochemistry, Microbiology or Biology or related discipline
• 1-3 years experience for MS or 2-5 years experience for BS in a pharmaceutical development laboratory environment
• Hands on experience using traditional analytical techniques.

• Understanding of cGXP requirements preferred
• Organization, communication and interpersonal skills.

• When laboratory management must be notified to determine whether an investigation is warranted.
• Whether they have been trained to perform a GMP task.
• Suitability of analytical equipment/instruments for use.