Robert W.

• Reviewed NDA/ANDA/BLA applications for process control and robustness across all dosage forms, while leveraging industry knowledge, to identify inspectional focus points in manufacturing and laboratory processes • Revised Post-Approval Inspection program, resulting in an enhanced risk-based approach to inspectional selection, utilized by the Office of Regulatory Affairs (ORA) and the Office of Compliance (OC) • CDER representative on complex manufacturing investigations; audited product specific processes and pharmaceutical systems, which led to regulatory action • Utilized ICH guidances in application reviews and led internal working groups to implement standardization of internal procedures, policies, and guidances • Led teams in developing creative solutions for complex compliance issues surrounding drug shortages and regulatory discretion, resulting in supply and assured product quality • Provided internal consults on process performance qualification, lyophilization and aseptic processing in order to maintain consistency across process reviews • Delivered succinct compliance and regulatory guidance pertaining to 21CFR 211 and 212 for pharmaceutical and positron emission tomography (PET) drug inquiries • Provided guidance to industry around manufacturing operations as the Office of Compliance, CGMP Lyophilization Contact

• Designed, managed and led clinical research trials at UNC Hospitals with an enrollment of 200 participants; performed and analyzed statistical analysis to assess differences in study population • Analyzed medical safety data for nephrology and heart failure clinical trials to support late-stage development and NDA submissions • Consulted on process performance qualification, lyophilization, and quality management, ensuring acceptance and approval of regulatory submissions

• Managed interdisciplinary team responsible for domestic and international sterile drug technical transfers • Selected and coordinated with Contract Manufacturing Organizations (CMOs) to deliver technical transfers ahead of deadlines through effective project and personnel management • Negotiated business contracts, statements of work, and master service agreements with third-party manufacturers to ensure lowest cost of goods while maintaining quality • Provided regulatory guidance (ICH, CFR, and USP) and training to small business partners in the US, Europe, and emerging markets • Conducted inspectional readiness and quality audits, prepared inspectional deficiency responses, and provided quality system corrective actions for CMOs • Generated competitive quotes and cost analyses for drug manufacturing in order to increase internal manufacturing business revenue • Supervised and trained operational and technical staff on capital projects and process improvement initiatives within the manufacturing facility; team consistently delivered ahead of schedule, resulting in cost savings and a decrease in operational deviations • Performed cost and operational efficiency analyses for manufacturing and laboratory operations; increased operational efficiency internally • Led technical investigations and designed and implemented corrective and preventive actions (CAPAs)

• Managed a team of eight technical and operational staff to ensure timely manufacturing and supply of clinical materials from CMOs to clinical sites; oversaw drug product related deviations • Collaborated with product development in designing manufacturing processes from early to late-stage manufacturing • Performed due diligence audits to ensure manufacturing site selection met business and quality needs • Wrote regulatory documentation for IND, NDA, and supplements for US and European agencies • Recognized as technical expert for formulation and fill-finish operations, investigation resolution, root-cause analysis, and CAPA implementation • Designed and executed technical studies, process performance qualifications, and electronic systems implementation to reduce deviations to less than one per month • Improved processes and designed systems utilizing six sigma, C4i, and other methodologies that resulted in savings in excess of $1 MM • Trained operators and support staff in aseptic gowning and proper aseptic technique; provided instructional training on manufacturing processes to various business areas • Hired operations personnel to ensure world class commercialization at $350 MM greenfield insulin cartridge and pen manufacturing facility • Designed efficiency analysis models to meet anticipated insulin business demand, thereby developing shift schedules for 24-hour manufacturing operations • Developed design requirements for facility and equipment, thus meeting CGMP standards and business needs • Reallocated to Indianapolis parenteral facility due to site closure