Analytical Chemist

• The Analytical R&D Chemist will support the Formulations Group in developing and validating analytical methods for raw materials and finished products, reverse engineering of formulation components and analysis of stability samples.

• The position will be primarily laboratory based and requires a strong background in chromatography and preferably in semi-solid dosage forms

• The candidate will have a proven track record developing and validating GMP-compliant HPLC & GC methods to assess drug substance and product stability, have experience diagnosing and troubleshooting HPLC instrumentation

• The scientist will routinely interact with other laboratory personnel, and will interact with vendors, customers, and business partners as necessary

• Prepares technical documents, including method development/validation protocols and reports, analytical test procedures, technical reports, change controls to support FDA submissions

• Executes method development and validation protocols for finished products

• Reverse engineer formulation components using sample preparation and analytical procedures.

• Evaluates the chemical and physical attributes of finished products such as pH, viscosity, water content, assay and content uniformity

• Maintain the analytical lab including calibration, performance maintenance and log books

• Ability to analyze, interpret and troubleshoot data

• Follow Company’s SOPs and ensure cGMP compliance

• Assists in the investigation of OOS/QR and OOT data and assist in writing investigative documents

• Responsible for maintaining laboratory housekeeping, cleanliness of laboratory equipment and workbenches, and other general lab responsibilities as assigned by supervisor

• Might require to work on extended hours on an as-needed basis