Provide technical support to ensure safe, reliable, and compliant cGMP API manufacturing by executing technical projects to optimize process control, yield, and purity.

Responsible for writing high quality proposals for various service offerings, specifically in support of early-stage development, including non-GMP and GMP manufacturing of APIs or drug substancesCollaborate with Business Development (BD) team, external customers, project managers, process development and analytical chemists on Requests for Proposals (RFPS)Preparation of detailed project proposals, including supporting materials such as Excel cost workbooks and high-level Gantt chartsMaintain accurate and timely updates to Salesforce.com in support of forecasting activitiesSupport finance in revenue and invoicing activities

Small molecule drug substance and drug product (API) manufacturing for clinical and commercial manufacturing management at various CMOs. Supported batch deviation root cause analysis, change controls, CAPAs, FMEA reports, PPQ validation, process characterization and development.

Expertise in process chemistry development and optimization for small molecule API synthesis and drug linker peptide synthesis for antibody drug conjugates (ADC). Process chemistry lead for Tukysa (Tucatinib) process parameter qualification (PPQ), and manager of process chemistry lab technician.Conduct large scale organic synthesis using insulated reactors up to 20 L. Extensive experience using Mettler Toledo EasyMax and RX-10 reactor systems for process development of various organic reactions. Safe handling of highly potent cytotoxic compounds using glove box isolators and laminar flow ventilated hoods. Run solubility studies for small molecule crystallization and precipitation conditions. Purify organic small molecules using normal and reverse phase Biotage and Teledyne Isco chromatography systems.Use of various analytical instrumentation to monitor reactions, analyze final products, and determine impurity structure: Agilent HPLC, GCMS, and LCMS systems using ChemStation software, 1D and 2D Bruker NMR experiments, Mettler Toledo in situ React IR, Karl Fischer (KF) water analysis, and DSC.

Process development and reaction optimization in small molecule API and peptide synthesis for antibody drug conjugates (ADC).Large scale peptide synthesis using insulated reactors.Analytical Agilent HPLC maintenance and troubleshooting. ChemStation software expert. Report analytical data for batch records and specifications.Solubility studies and peptide crystallization or precipitation conditions.Skilled use of Karl Fischer moisture analyzer.

Design, synthesize, and submit small molecule compounds for various therapeutic areas (oncology, neuroscience, pain etc) as potential drug candidates.* Route scouting and reaction troubleshooting, high productivity and reaction metrics.* Conduct organic reactions on mg to 100 g scale.* Expertise in metal catalyzed coupling reactions, heterocyclic chemistry, and amide coupling reactions.* Interpret in vitro and in vivo bioassay data, structure activity relationships, and molecular modeling to direct further research.* Head of high pressure reactions for lab: monitored and maintained a portable high pressure hydrogen tank for my lab and assisted chemists in running high pressure hydrogenations safely. * Co-present posters on project research at internal poster sessions* Teambuilding and mentorship.* Extensive knowledge of various instrumentation and their maintenance including: NMR, MPLC, HPLC, LCMS, rotary evaporator, microwave reactors, and lypholizer.* IT expertise with: SciFinder, Reaxys, DS Viewer Pro, E-notebook, Inventory programs, PowerPoint, Microsoft Works, ChemDraw, Word, Outlook, and Excel.* Safety Representative: performed audits of other labs to assess that safety protocols were being upheld.

Synthesis, purification and characterization of various small molecule drug candidates in varying scale for multiple therapeutic areas. Helped design new and novel potential drugs for customer projects. * Extensive amide coupling libraries and peptide synthesis. * Use of various instrumentation on a daily basis including: NMR, HPLC, LCMS, rotary evaporator, Combiflash or MPLC, and lypholizer. * Updated customers on a bi-weekly schedule through PowerPoint and phone conferences that resulted in continuation of customer projects.* Information Technology and Software experience with: SciFinder, Reaxys, Inventory programs, Microsoft Works, PowerPoint, ChemDraw, Word, Outlook, and Excel.