QC Lab Supervisor

• Aug 2022 - Present

Senior Scientist

• Jul 2021 - Aug 2022

• Project manager for analytical support for projects including delegation to junior chemists, analytical tasks in support of product development, registration lot release, pre and post regulatory submission activities. • Develop and validate methods for drug substances and finished products. Write, review, and approve technical documents such as validation protocols/reports, SOPs, technical packages, stability protocols/reports, stability specifications, test methods, vendor qualifications, and certificates of analysis. • Lead investigations to successfully resolve analytical problems, project issues, and deviations. • Present data at project-related meetings including to the FDA. Participate in cross-functional project teams. • Mentor junior chemists in method development, method validation, instrumentation, troubleshooting, and lab practices.

Senior Scientist

• Nov 2019 - Jul 2021

Perrigo is now Padagis Perrigo is now Padagis

Senior Scientist

• Oct 2017 - Nov 2019

• Technical project manager identifying, developing, and performing required analytical tasks in support of product development, registration lot release, pre and post regulatory submission activities. Includes trouble-shooting and managing resources for executing testing to meet filing dates. • Develop and validate methods for small molecule drug substances and finished products. • Write, review, and execute method development reports and method validation protocols. • Project lead of CRL/IR team formed to reduce number of deficiency letters for filings. • Mentor junior chemists in method development, method validation, instrumentation, troubleshooting, and lab practices.

Analytical Researcher III

• Dec 2016 - Sep 2017

• Write, review, and execute method development reports, method validation protocols, and method validation reports for NTE (New Therapeutic Entity) abuse deterrent controlled substance pharmaceuticals. • Perform and develop routine pharmaceutical testing methods as well as abuse deterrent methods such as MTAR (Multi-Tablet Abuse Resistance)/food effect dissolutions, insufflation, and syringeability. • Member of global ELN team which responsibilities include form design, quality control form testing, and form implementation training. • Coordinate AQbD practices across the analytical department as a member of the CIMA labs AQbD team.

Senior Researcher

• 2008 - Sep 2017

• Write and review analytical method validation and method comparative protocols and reports for solid dose oral drugs (IR and ER), suspensions, creams, buccal films, and raw materials following ICH guidelines. • Supervised scientists and managed schedule for stability testing of ANDA submissions for lab group. • Perform method development for impurity, assay, and dissolution using QbD practices. • Expedient support testing for DOE formulation matrices. • Implemented an ASAP (Accelerated Stability Assessment Program) for pre-validation formulation screening for excipient/drug substance interactions that would become problematic in filing stability studies. • Taught learning modules on how to use the Sotax AT70 Smart Automated Dissolution device, how to expedite LIMS entry, and hands-on scientist ELN training.

Associate Scientist

• Mar 2008 - Jul 2008

See above See above

Chemist II

• Sep 2006 - Mar 2008

• Test Raw Material and Excipients following USP and In-House guidelines. • Trouble-shoot OOS results. • Optimize testing within QC guidelines and submit to LTS (Laboratory Technical Services) for further method development. • Perform method transfers. • Extensive testing of controlled substances following DEA protocols. • Chairperson of Laboratory Operations Safety for day-shift activities. • Test Raw Material and Excipients following USP and In-House guidelines. • Trouble-shoot OOS results. • Optimize testing within QC guidelines and submit to LTS (Laboratory Technical Services) for further method development. • Perform method transfers. • Extensive testing of controlled substances following DEA protocols. • Chairperson of Laboratory Operations Safety for day-shift activities.

Research Associate

• 2001 - 2005

• Medicinal chemist in Oncology team with specialization in VEGF receptor inhibition. • Optimize existing synthetic routes for production of purified compounds for in-vivo testing. • Co-write papers for submission to scientific journals. • Medicinal chemist in Oncology team with specialization in VEGF receptor inhibition. • Optimize existing synthetic routes for production of purified compounds for in-vivo testing. • Co-write papers for submission to scientific journals.

Undergraduate Research Assistant

• Jun 2000 - May 2001

• Assist in the synthesis of a heterocyclic marine natural product under the guidance of Professor James Panek. • Assist in the synthesis of a heterocyclic marine natural product under the guidance of Professor James Panek.