• Provide leadership and work with CROs/CMOs to design and perform method development and validation employing phase-appropriate approaches at different stages of development for assay, purity and dissolution methodologies, identification of impurity and degradation products, reference standard qualification and physical (solid-state) characterization.• Coordinate, monitor and evaluate project progression at contract manufacturers and ensure the timeliness and quality of deliverables.• Review and provide oversight of all documentation related to the analytical testing of drug substance and drug product, including but not limited to development reports, validation protocols/reports, stability protocols/reports, deviations, etc. Ability to lead or conduct a root cause analysis and implement proposed corrective actions at CRO/CMO.• Author/review analytical sections of CMC modules in regulatory documents including IND, IMPD, NDA, MAA and other regulatory submissions.• Oversight of GMP QC activities (release and stability testing, investigations) for clinical, registration, and scale-up lots• Supported manufacturing campaigns, impurity fate and purge and DOE studies• Contributed to RSM and GMP intermediate methods qualification strategies • Led specifications, retest period, and shelf-life establishment for clinical and registration lots• Managed reference standards, reference materials, and retention time markers (re)qualification• Participated in planning of analytical resources, timelines, and budget

- Provided technical expertise on analytical methodologies for small molecules and ASO drug substance and drug products-Performed Phase III readiness assessment for different products going from Phase I/Phase II into Phase III and from Phase III to Commercial including evaluating the state of analytical methods and specifications and their compliance with ICH requirements and global market regulations.-Troubleshoot and lead complex analytical investigations-Author and review analytical method and validation sections of regulatory filings and address the questions from the global regulatory agencies-Design analytical method transfer and validation studies, execute and coordinate execution within QC or in external contract laboratories-Author and review transfer and validation protocols/reports -Review and optimize analytical methods to make them robust and QC friendly for GMP testing and ensure compliance with global regulatory agency guidelines-Technical SME working with contract laboratories across multiple regulatory markets-Manage projects across sites, cross-functional areas and with collaborating companies; develop timelines and communicate priorities to leadership and stakeholder-Collaborate and communicate with stakeholders in manufacturing, manufacturing sciences, regulatory and QA

Manage analytical technical transfers at European CMO for commercial productsStrengthen business relationship with CMO/CRO Successful completion of transfer activities in compliance with ICH, FDA and EMA regulationsCollaborate with QA during CMO QA auditsReview and approval of laboratory investigations, protocols, specifications, test methods and analytical reports

Supported NDA filing by authoring method validation sections, reviewing data and participating in internal auditsContributed to justification of specification for dissolution method involving a combination productManage review of CRO method validation data and reportsProvided training and manage a team of consultants working on electronic data integrity project

Lead Laboratory Investigations and Deviations team for Analytical OperationsWork with Quality consultants to enhance our Deviations and CAPAs quality systemManage GMP & Method Training Team Evaluate and revise Analytical Operations SOPs Supervise chemists conducting method validationAuthor method validation protocols and reports Support internal auditsSupport FDA audits

Applied LCMS technique to ensure suitability of LC assay/impurities methods. As a result, a degradation product discovered in Tybost® during Phase III was successfully characterized and a suitable method was developed to quantitate this impurity.Supported regulatory filings by writing and reviewing analytical development sections with emphasis on stability data.