- Leading multiple projects in development, optimization, and assessment for analytical methods for raw materials and in-process, intermediate and final APIs complying ICH/FDA guidelines under cGMP environment
- Verification and optimization of compendial test methods (USP/EP)
- Reviewing protocols for analytical methods, validation, validation reports, and SOPs
- Conducting forced degradation studies complying FDA guideline
- Performing unknown impurity identification in raw material, clean-out samples, R&D samples using LC-MS (high resolution MS) and GC-MS
- Reviewing and revising specification sheets, change controls, batch records, and LIR
- Providing technical and analytical supports to R&D, QC and production teams
- In-house standard qualification establishing COA of reference standards
- Communication with customers in verbal and written formats to present interim and final results and work progress
- Engage in route scouting, design process, route planning and process optimization for cGMP production of APIs and coordinate in the preparation of process documentation.
- Develop and perform process research to identify the most cost-effective and sustainable route as early as possible.
- Responsible for synthesis, characterization, scale up for preclinical and support for commercial production of drug substances (API's) and drug products (DP's), technology transfer with regulatory compliance.
- Ph. D. in Analytical Chemistry, Organic Chemistry, or Chemistry
- Passion for learning
- GMP experience preferred, but will accept 1+ years of Post Doctoral research experience