- Work independently in method development and validation of in-house methods and verification and qualification of compendia test methods (HPLC, GC/headspace, and dissolution). This includes API evaluation, impurity profile, dissolution profile for solid dosage controlled-release product, specification setting, and product stability evaluation.
- Improve lab systems and procedures in accordance with applicable regulations (i.e. cGMPs, cGLPs, ICH and FDA) including anticipating emerging requirements.
- Analytical support to product development for validation of cleaning and manufacturing process and technology transfer.
- Stability testing, investigation and data review as assigned by supervisor.
- Maintains a heightened proficiency with data acquisition systems and other computer software.
- Maintenance and Calibration of analytical instrumentation.
- Writing analytical methods, SOPs, protocols, and technical reports.
- Assists the supervisor in training junior level chemists.
- Set-up and IQ/OQ of new analytical instrumentation.
- Procurement assignments/responsibilities.
- Other responsibilities as assigned by the Supervisor

- Bachelor's degree (B. S.) in chemistry or related field with at least 10 years experience and/or training or Master's degree (M.S.) with at least 5 years experience and/or training; or a Ph.D. with at least 5 years experience and/or training.
- Experienced in analytical method development and validation in pharmaceutical cGMP/cGLP environment and familiar with FDA and ICH guideline in analytical method validation are essential.
- Prior experience with Waters Millennium™ data acquisition software is a plus.