Assist in all aspects of R&D laboratory compliance and management including managing the controlled substances program, ELN administration, protocol and data review, and instrument repair and qualification. Review all analytical and formulation raw data that is generated for completeness and accuracy as per approved methods and/or applicable protocols. Review data tables generated for reports for accuracy. Ensure all documentation meets GLP standards. Review protocols for instrument IQ/OQ/PQ and review all PM and qualification reports after any service.Manage the controlled substances program. Maintain DEA compliance by issuing controlled substances to users. Review all necessary forms and maintain controlled substances inventory. Perform quarterly inventory and reconciliation of all controlled substances on site and participate in DEA audits. Support ELN administration by communicating issues that users encounter. Support implementation and updates of templates in the system. Author SOPs and Work Instructions to help team members perform their activities in the R&D group. Review and revise SOPs biennially when they are due for periodic review. Provide training to R&D team members, as needed.

Developed and validated analytical methods. Provided analytical support for drug products from discovery to commercialization. Helped to support a NDA submission.

Led development, authoring, and transferring of all analytical methods for multiple projects from pre-development through commercial stages. Visited CMOs to train analysts on methods when necessary.Performed all sample testing including stability protocols to test assay and related substances by HPLC and / or UPLC, particle size analysis, dissolution, UV-Vis absorption, water content, and fluorescence microplate reader. Prioritized sample testing and multi-tasked duties to keep up in a fast-paced work environment. Taught other scientists specific methods, techniques, and / or instrumentation to advance the scientific knowledge in the lab. Attended seminars at the Eastern Analytical Symposium and prepared presentations to share learnings with colleagues.Responded quickly to all inquiries from the FDA. Recognized by management with an award for continued commitment to excellence for contribution to managing deficiency responses.

Worked with generic drug formulations (suspensions, ophthalmic solutions, lyophilized products, and pen projects). Developed, validated, and transferred analytical methods. Tested stability of samples to determine assay and related substances by HPLC and/or UPLC. Performed other sample testing as required for formulation support including particle size analysis, dissolution, water content, and UV-Vis absorption.

Performed molecular beam epitaxy to produce semiconductor wafers, performed tests to make sure the wafers met customers’ specifications, and edited growth parameters by analyzing SPC charts. Troubleshooted problems when they arose with engineers.

Tutored two students in Chem 351: Biochemistry Survey an hour per week. Both students improved at least 20 points on second from first exam.

Provided pre-lab discussions, reviewed material from lectures, taught lab skills, assisted in lab, answered questions, and graded papers.