Provides analytical support of product development, including sample analysis and method pre-validation, accurately and concisely documents data, and reports results. Performs various analytical testing, including dissolution, HPLC and GC testing following established testing procedures for raw materials, finished products, and/or stability samples.
The Analytical R&D Chemist I reports into the Manager, Analytical R&D.
- Perform routine sample analysis requiring general laboratory skills such as weighing, pipetting, titration, and basic operation of laboratory instrumentation
- 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
- Operation of software to collect, process and calculate and report analysis data.
- Perform testing to evaluate physical characteristics of raw materials and finished products
- Work under direction provided by supervisor
- 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.
- BS or MS in Chemistry, Biochemistry, Microbiology or Biology or related discipline
- 0-2 years experience for MS or 1-3 years experience for BS in a pharmaceutical development laboratory environment
- Understanding of cGXP requirements preferred
- Organization, communication and interpersonal skills