Led team to complete analytical transfer efforts to transfer API, key raw materials, and Intermediates from Gilead to PharmaChem ahead of schedule for process validation in a new plant. Project manager for Empower 3 software implementation and instrument changeover from OpenLab to allow for remote connection to instruments, as well as being able to remotely review and process lab results.

Create systems and processes for operating four blogs, onboard new freelancers, and assist with day-to-day operations.

Expanded lab capabilities to support in-process pilot plant operations for GMP API process development.Performed raw material release, bulk solvent release, water quality testing, and pilot plant equipment cleanout testing using UPLC, GC, IR, UV, TOC, KF, titration, and Conductivity analyses.Lab Safety representative: ensure adherence to site and environmental safety regulations. work with site safety to identify and eliminate near misses.

• Led effort for software upgrade to qualify ICP-MS for GMP analysis and to streamline method loading procedure.• Provide elemental analysis support to all projects in Merck’s development pipeline. Efficiently analyze samples for heavy metals and USP/NF regulated elements by ICP-MS and ICP-OES/AES. Provide real time support for critical pilot plant samples.• Developed ICP methods to test low levels of Potential Genotoxic Impurities (PGI).• Perform regular maintenance of ICP-MS and ICP-OES.• Train employees on the theory and use of walk-up ICP-OES instrument.• Led successful implementation of 5S in AAS Group.• Responsible for lab maintenance including ordering lab supplies, instrument parts, and standards, as well as performing calibration of instruments.• Safety representative for AAS Group. Ensure adherence to site and environmental safety regulations. Work with site safety to identify and eliminate near misses.• Developed and implemented TeamSpace for AAS Group to serve as a one-stop website for FAQs, contact information, and sample submission. • Manage digital data repository for results by developing naming convention and organization system, eliminating >99% of paper waste.• Presented poster to showcase group’s capabilities at Merck’s networking events.

• Led analytical chemistry support for multiple projects in various stages of development. Collaborated with Process Chemist and Chemical Engineers to meet project deadlines.• Developed robust achiral and chiral chromatographic methods for new chemical entities which included method characterization, separation of impurity, stability study, specifications setting, assay for starting materials, intermediates and final product, PGI analysis, chiral and achiral column screening. • Validated HPLC and GC test methods to the appropriate development stage according to the current SOPs.• Performed troubleshooting on HPLC, GC, and KF instruments.• Optimized chromatographic methods and sample preparation procedures.• Initiated technology transfers, assisted in compiling responses to FDA and prepared all necessary documents for IND filings.• Performed delivery testing to provide quality material within expected deadlines for clinical trials, formulation, and safety studies.

• Maintained in-process laboratory operations and commercial testing using current Good Manufacturing Practices (cGMP).• Provided support for plant operations, chemical engineers and process chemists with design of experiment for batch records associated with the release of Phase II Clinical Trials active pharmaceutical ingredients (API).• Validated analytical methods for the release of API, key intermediates, and raw materials.• Certified reference standards for quantitative and qualitative use to identify impurities and assign potency of API.• Performed calibration and daily verification of various laboratory instruments.• Performed quarterly calibration of HPLC (including Detector, Pump, GPV, Injector and Linearity) and GC (including Oven, Detector Flow Accuracy and Linearity).• Performed all necessary cGMP analytical tests to identify, characterize, and assign purity and potency for batches used in Phase II Clinical Trials. Analytical tests include: FTIR, KF, Particle Size, LC Area percent, LC Assay, X-Ray diffraction, pH, Residue on Ignition, Metals content by ICP, Loss on Drying (LOD), Cyanide test (when necessary) and Residual Solvents by GC.

• Managed a group of ACS Project SEED students and provided guidance for research projects.• Independent Research. Poster presentations:o Protein Purification from Bovine Milk, ACS National Meeting in Atlanta, GAo Use of Geospatial Techniques and Chemical Analysis to Track Contaminants ACS National Meeting in Atlanta, GAo Trace Metal and Ion Analysis in Soil and Water, ACS National Meeting in Philadelphia, PA.