-Responsible for R&D pharmaceutical stability program-Manage pharma R&D stability studies for CTM and new product submissions-Coordinate stability requirements with project teams and write stability study protocols -Stage stability materials and maintain stability LIMS database (ScienTek) -Provide supervision for reference standards program -Coordinate in-house analytical testing and testing with external vendors-Write and revise analytical testing protocols -Perform analytical testing per local SOPs and compendial methods (USP/NF and EP)-Project Manager for Nutritional Lab project-Worked as a team leader in the planning, negotiating, and supervision of a new lab build for nutritional supplements testing-Wrote testing protocols, technical memos, and final reports for nutritional method verifications and method improvements-Project completed under budget -Provide support for global LIMS database -Assisted in test script development and execution for stability database-Supported process verification, master data creation, and new study development and testingSkills• Chromatography (HPLC, GC)• Spectroscopy (UV-Vis, FT-IR)• Microscopy (Particle Size Limits)• Empower 3 chromatography software• CATSWeb software (OOS/OOT, NC, CAPA)• LIMS software (ScienTek, LabVantage Sapphire)

- Provided support for R&D pharmaceutical stability program- Managed pharma R&D stability studies for CTM and new product submissions- Wrote and revised SOPs, Central File Reports, validation protocols, and validation final reports. - Responsible for physical and chemical analyses of vision care and pharmaceutical products

- Supported method development and validation for pharmaceutical assay/impurities methods- Provided analytical support for new vendor API development and validation - Empower software System Administrator

- Provided analytical testing support for successful NDA submission; supported next generation product development- Assisted with contact lens analytical testing and method validation

-Responsible for chemical and physical analyses of raw materials and intermediates in a cGMP lab environment -Setup and qualified new instruments; wrote new instrument use procedures

-Responsible for chemical and instrumental analyses of organic peroxides -Assisted in method development and method writing working both independently and as a project member-Analyzed non-routine samples for in-process troubleshooting, process optimization, and new process development-Worked as a project member in the development and setup of fully-equipped analytical labs in manufacturing areas and in training process operators to conduct analytical testing during manufacture