Creating and supporting internal GMP Quality processes and systems to streamline vendor oversight of analytical, QC, and QA operational activities. Managing Quality team to coordinate and accomplish day-to-day QA and QC operations. Providing oversight and conducting Quality reviews for in-process, raw material, and final product testing for the GMP manufacture of drug substances and drug products as well as for analytical method development, validation, and transfers for multiple projects at the clinical stages. Leading CMC QC activities for regulatory submissions. Effectively managing teams at multiple CMOs and CROs to meet the program timelines and objectives. Providing oversight and support for Quality Documentation. Authoring and reviewing multiple SOPs and work instructions detailing Quality procedures.• Creating Quality systems to manage the QC review process, reference standard program, and stability program.• Creating QA operational systems for batch disposition to support clinical GMP manufacture of drug substances and drug products.• Quality lead for the establishment and management of specifications for multiple programs.• Leading CMC QC activities to support regulatory filings including IMPD and filings for multiple programs.• Effectively partnered with CMC to ensure the successful GMP manufacture of clinical candidates and their successful progression through development to government filings with the competent authorities.• Reviewing and assessing trends observed in batch histories and stability testing for API and Drug Product to support the setting of appropriate specifications throughout development to commercialization.• Overseeing the QC support for analytical, drug substance, and drug product development activities to ensure accuracy of data.• Mentoring and supporting Quality Documentation in the implementation of Veeva EQMS and Veeva Learn GXP company-wide.

Created QA and QC clinical and commercial systems to streamline vendor oversight of operational activities. Managing an internal team of 4 to coordinate and accomplish day-to-day QA and QC operations. Provided Quality oversight and conducted reviews for in-process, raw material, and final product testing for the GMP manufacture of APIs and drug products as well as for analytical method development, validation, and transfers for multiple projects at the clinical and commercial stages. Led all QC activities for regulatory submissions. Effectively managed teams at multiple CMOs and CROs to meet the program timelines and objectives. • Effectively led a team of 7 for all regulatory CMC QC activities which included the QC of over 100 FDA and EMA responses to the NDA and MAA submissions, eight of which were major objections. Worked closely with the expanded cross-functional teams, providing updates and metrics while meeting an aggressive regulatory timeline.• Mentored and managed the growth and development of an internal QC/QA team.• Developed and implemented in house Quality systems to manage the QC review process, reference standard program, QA deviations review tracking, and stability program.• Oversaw the implementation of commercial QC systems to support commercialization of BylvayTM.• Created QA operational systems for batch disposition to support both the clinical and commercial GMP manufacture of drug substances and drug products.• Managed the Quality oversight and timeline for multiple GMP operational projects.• Quality lead for the establishment and management of specifications.• Effectively partnered with Technology Operations, QA, and Regulatory departments to ensure the successful GMP manufacture of clinical candidates and their successful progression through development to government filings with the competent authorities.• Oversaw the QC support for analytical, drug substance, and drug product development activities to ensure accuracy of data.

Created a QC gap assessment and implemented processes to streamline internal QC activities and improve vendor oversight. Managed an internal team of 3 to coordinate and accomplish day-to-day QC operations. Provided analytical review for in-process, raw material, and final product testing for GMP manufacture of API and drug product as well as QC review for analytical method development, validation, and transfers for multiple projects at the clinical stage. Support QA with the management of batch disposition, deviations management, and internal documentation retention. Effectively managed teams at multiple CMOs and CROs to meet the challenging program timelines and objectives. Authored and reviewed multiple SOPs and work instructions detailing analytical and QC procedures.• Mentored and managed the growth and development of an internal QC team of three.• Developed and implemented in house QC systems to manage the review process, reference standard program, and stability program.• Managed the QC technical oversight and timeline for multiple projects.• Quality lead for the support of the establishment and management of specifications.• Led QC activities to support regulatory including IMPD, IND, NDA, and MAA filings for multiple Albireo programs.• Effectively partnered with other members of Pharmaceutical Development, QA, and Regulatory to ensure the successful GMP manufacture of clinical and commercial products and their successful progression through development to government filings with the regulatory authorities.• Provided QC support for analytical, API, and drug product development activities to ensure accuracy of data.• QA designee for temperature excursions, specifications, methods, stability protocols/reports, and reference standard management including qualifications and requalifications.

Led analytical method development, validation, and transfers for multiple projects at the clinical stage and provided analytical support for NDA activities. Effectively managed teams at multiple CMOs and CROs to meet the program timelines and objectives. Authored and reviewed multiple SOPs and work instructions detailing analytical procedures.• Developed the iStability program to manage the stability monitoring and created the cross functional structure between Pharmaceutical Sciences, the QC, QA, and Regulatory in support of regulatory filings with the competent authorities.• Trained incoming team members from the QC, QA, and Analytical departments on data entry, data review, and administrative support for the iStability program.• Managed the method development, validation, and implementation of phase appropriate analytical methods at CMOs and CROs in support of API and drug product development for two drug candidates across all stages of development.• The main analytical contributor in CMC activities to support regulatory filings (IMPD, CTA, IND) for multiple development programs.• Effectively partnered with Pharmaceutical Sciences, QC, QA, and Regulatory to ensure the successful GMP manufacture of clinical candidates and their progression through development to regulatory filings with the competent authorities.• Creating structure for assessing analytical trends in batch histories and stability results to ensure consistent reporting.• Assisted with the NDA and MAA filings for KPT-330 by editing and reviewing stability sections; performed and managed analytical activities in preparation for the filing and in response to filing questions; and reviewed multiple source documents to ensure accuracy.• Developed and managed the reference standard program in partnership with the QC department.

Lead analytical method development, validation, and transfers for multiple projects at the clinical stage and provide analytical support for NDA readiness activities. Review and approve analytical methods, protocols, and reports for validation and stability studies. Manage CMOs and CROs to meet the program timelines and objectives.• Develop, manage, and lead the iStability program and the cross functional work flow between Pharmaceutical Sciences, the Quality Unit, and Regulatory departments in support of regulatory filings with the competent authorities.• Manage the method development, validation, and implementation of phase appropriate analytical methods at CMOs and CROs in support of drug substance and drug product development for two drug candidates across all stages of development.• Manage the technical oversight and timeline for multiple projects.• Review and approve method development reports as well as method validation protocols, data, and reports.• Assist in CMC activities to support regulatory filings (IMPD, CTA, IND/NDA) for multiple Karyopharm development programs.• Work closely with other members of Pharmaceutical Science, the Quality Unit and Regulatory to ensure the successful GMP manufacture of Karyopharm clinical candidates and their successful progression through development to government filings with the competent authorities.• Conduct checks and review of data generated by contract sites for source accuracy and traceability.• Review and assess trends observed in batch histories and stability testing for API and DP to set appropriate specifications throughout development to commercialization• Assist in the management of the analytical reference standards and impurities

Developed and optimized in vitro release methods in collaboration with Process Development and research departments. Led and assisted in method validation activities for in vitro release, lipid chemistry, and drug encapsulation. Assisted in method transfer as the in vitro release subject expert. Performed routine release and stability testing. • Redeveloped the MM-398 in vitro release assay in three months in response to the FDA pre-NDA, Type B preliminary meeting comments, meeting the accelerated timeline for NDA filing.• Collaborated with the Process Development group to determine the discrimination capabilities of the MM-398 in vitro release assay and performed statistical analysis using the model independent approach using similarity and difference factors to demonstrate these discrimination capabilities.• Led method development activities for the MM-436 in vitro release assay.

Performed and managed cGMP in-process, release and stability testing for multiple projects in line with global project deadlines. Reviewed in-process and release testing results from CMOs in conjection with batch dispositions. Developed and maintained batch histories for key intermediates and APIs. Authored and reviewed QC sections in IMPD and IND filings. Subject matter expert and QC leader for various project and CMC teams.• Initiated and executed analytical method transfers for an 8 stage chemical process to multiple global CMOs within a year to meet the drug development timeline.• Interacted with global CMOs to ensure Eisai expectations and project time lines were met.• Initiated method validation in Phase 1 of drug development to proactively prepare for an accelerated Phase 3 drug development timeline.• Collaborated with Analytical and Process Chemistry departments to troubleshoot and optimize analytical test methods.• Performed data trending and analyses to identify impurities and impurity growth in key intermediates, API, and stability studies.• Developed and performed parameter evaluation studies to investigate potential starting materials.• Initiated deviations, change controls, CAPAs, and OOS per site SOPs.• Trained QC personnel on analytical thermogravimetric analysis (TGA) techniques and use of the lab instrumentation.• Trained and supervised contractors in performing analyses for various projects.

QC lead for the cGMP release and stability testing for various Phase 1 and Phase 2 development projects. Collaborated with technical and research groups to identify project impurities. Responsible for maintaining safety compliance within the QC laboratories, cGMP quarantine and release areas.• Collaborated with Process Chemistry department to develop and execute testing protocols for spike purge studies which provided analytical support in impurity tracking throughout projects’ process.• Increased efficiency and enabled multidiscipline communications by developing network system folders for batch testing results.• Initiated and executed TGA experiment to identify reasons for unexpected residue on ignition results on multiple API batches.• QC NMR analyst lead. Reduced costs of using outside vendors by proactively becoming the first QC member to be trained on running NMR analyses for the QC department. Trained QC colleague on usage of the instrumentation to enable the QC group to handle the higher demand.

QC analyst for cGMP batch processes conducted in the kilo lab and pilot plant. Conducted stability testing for Phase 1 and Phase 2 projects. Reconciled retain inventories to ensure accuracy. Developed a working knowledge of 21CFR Part 11 and change control process.• Initiated and executed change control to add new instrumentation to the validated network system meeting an accelerated pilot plant production deadline.• Designed a shared QC retain Excel spreadsheet database to provide a more transparent inventory system for the planning of experiments by Analytical and Process Chemistry departments.• Key contributor to the Halaven® analytical method transfer to Analytical and QC groups at Eisai Co., Ltd in Kashima, Japan.• Produced batch release data for the CMC section of the NDA filing of Halaven®.• Assisted in optimizing methods for consistent results by collaborating in the development new material handling procedures for highly hygroscopic and electrostatic APIs.• QC TGA analyst lead which led to meeting the higher demand for quicker %ROI and %volatile results. • Trained newer QC personnel on analytical techniques and use of lab instrumentation.

Analyzed and managed raw materials inventory used for kilo lab and pilot plant productions for both cGMP and scale up research use. QC lead in all raw materials sampling and testing. Assisted in in-process and release testing during batch campaigns. • Key contributor in identifying sampling room needs to meet the requirements of material flow for the GMP compliant warehouse.• Optimized and coordinated communication with the off-site vendor warehouse to streamline the flow of raw materials including sampling, testing, release status and quantities.• Trained and supervised QC colleague of the QC Raw Materials systems and testing to ensure consistency and compliance between QC analysts.• Achieved difficult project deadline by collaborating and implementing an efficient raw materials sampling and testing solution to release raw materials.• Participated in internal audits of the raw materials quarantine and release rooms.