• Manage a team of twenty scientists focused on company process development growth.• Orchestrate testing support for five BLA-approved programs. • Achieving >80% adherence to KPI metrics for 4 years running, in group that supported 2000-4000 samples/month.• Pilot automation technology A2P2 (Auto Assay Prep Platform) to automate and streamline current Protein A purification/titer/product quality assay analysis.• Increase productivity by 400% by creating playbook to streamline Tecan RoboColumn® purification procedure.• Lead workshops with cross-functional leaders to identify and pursue opportunities to enhance testing cadence, team processes, and program outcomes.• Review product and process characterization data and analytical method qualification protocols and reports.• Resolve external capillary electrophoresis (CE) method that created artificially high level of fragmentation to make program timeline for high visibility program.• Troubleshoot chromatography, CE and compendial analytical methods.

• Managed a diverse fifteen-member team responsible for high throughput process analytics and external staffing vendor relationships to support commercial process development, process characterization, and product characterization for late-stage clinical programs.• Mentored and trained direct reports by holdings weekly one-on-one to set professional development objectives and maximize team performance.• Developed resource forecasts for ten active programs, oversee on-boarding of new programs, and provide program updates to management.• Designed and implemented strategies to increase year-to-year productivity and optimize operational efficiency in collaboration with cross-functional senior leadership team.• Analyzed 250 CE samples/month to ease team’s sample load.

• Managed commercialization activities for a late-stage clinical program and associated method lifecycle activities.• Optimized current systems’ design to increase efficiency and decrease assay turnaround times, including new lab setup, Empower 3 Templates, and weekly safety walkthroughs.• Oversaw daily operations and long-term planning for four analysts responsible for routine and non-routine HPLC and CE analyses to support commercialization of late-stage pipeline molecules (process and product characterization and method optimizations in support of validation).• Monitored rapid analytics team’s performance, compliance, and data integrity practices.

• Conducted and monitored experiments designed to generate robust and reliable data using Waters HPLCs, UPLCs and Beckman Coulter CE systems in a high throughput environment.• Performed high throughput assays for product and process development samples.• Developed systems to troubleshoot equipment and experimental difficulties.

• Conducted and monitored experiments designed to generate robust and reliable data using Waters HPLCs, UPLCs and Beckman Coulter CE systems in a high throughput environment.• Performed high throughput assays for product and process development samples.• Developed systems to troubleshoot equipment and experimental difficulties.

• Responsible for characterization of small molecule candidates, method development, qualification, and validation, and stability testing of API and drug products under GLP environment using Water HPLCs (Empower Software)• Perform protein analytical assays such as HPLC analysis, SDS-PAGE, IEF Gel, and ELISAs • Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results• Prepare and present technical documents such as reports, SOPs, and presentations to various team members

• Collaborated with senior scientists to synthesize proprietary N-halamine compounds, developed new formulations, and oversaw the application of new formulations at manufacturing facilities.• Developed, drafted, and implemented new QA/QC procedures, batch production records, and SOPs to test finished products for manufacturing facilities.• Successfully transferred technology to Pakistan commercial site to meet product retail release date. • Provided remote and onsite technical support to manufacturing facilities and partner companies by investigating abnormalities and implement corrective actions when products are out of specification.• Mentored and trained international manufacturing facilities personnel on QA analytical techniques and procedures.

• Performed established EPA’s Methods 8330 and 8832 to analyze explosives by HPLCs and Northwest Total Petroleum Hydrocarbons test method via GC on soil and water samples.• Packaged data and wrote narratives of the results provided to clients.