Boston, Massachusetts, United States
• MBA and M.S. Finance Graduate in Boston College’s Carrol School of Management • Effective operations and cross functional leader with experience in commercial and clinical scale pharmaceutical manufacturing, process development, and tech transfer • Provided operational and technical leadership during new product introductions, drug product regulatory filings, risk assessments, CAPAs, Change Controls, Deviations, Validation, PPQ, IQ/OQ
Acts as main point of contact for CDMO(s) including leader of CDMO working teams and strategic business review chairperson. Responsible for Long Term Strategic supplier management and accountable for Supplier Relationship Management (SRM) and SRM related processes for given CDMOs. Responsible for driving execution of Drug Product Intermediate production plans: Provide operational oversight and troubleshooting support to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management). Responsible for driving execution of the production plan at CDMO. (PO through delivery). Partners with MS&T, Quality and CMSC Strategy and Business Operations to champion a culture of quality with our CDMO’s and to ensure that all activities and documentation comply with regulatory requirements. Establish a robust tracking and reporting process to monitor CDMO performance using a set of standard KPIs (Key Performance Indicators) and report progress to management. Leads identification and resolution of business/contract issues (bring in legal, CMSC LT, Strategy +Bus Ops, Strategic Sourcing) Partners with Vendor Management, Strategic Sourcing and Strategy and Business Operations to further develop our Supplier Relationship Management and Supplier Contracting Programs. Partners with Global Supply Chain to develop long term manufacturing network strategy and to maintain a flexible, reliable, robust, and cost-effective manufacturing network. Champions a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement
Reporting directly to the Chief Development Officer, coordinating across programs, department heads at VP levels. Managing annual budget for R&D organization, including forecasting, program management, budgeting, and portfolio management. Worked cross functionally to create unified organizational systems and collaboration with various stakeholders internally and externally.
Served as technical lead for drug product and API process engineering by acting as technical lead for Glaukos East organization Led cross functional teams when implementing process updates at external manufacturing organizations Coordinated technical process development of commercial drug product processes at CMOs Led technical transfer efforts to ensure drug product processes were transferred and scaled up according to IND and FDA regulatory submissions Led discussions with external partners to support development, qualification, supply, and cGMP manufacture / packaging labeling. Created equipment user requirements, conducts FAT, Process Characterization and Validation in all sterile fill finish processing areas Maintained critical quality attributes, in-process and release data tracking and trending analysis as well as in-process equipment parameter tracking and trending analyses. Maintained compliance and efficiency during tech transfers and at CMOs to drive the organization to current manufacturing standards Collaborated with R&D drug development teams in the early stages of drug development to ensure manufacturability at commercial scale
• Led operational efforts across client facing programs to ensure the successful manufacture of gene therapies • Monitored information flow and acted as gate keeper when necessary: weighed in on operational decisions after assessing potential impact • Reviewed client contracts to ensure financial milestones were on schedule and compliantly attainable • Presented and communicated to internal and client joint leadership teams (Chief Operating Officer Level) to support strategic decision making for the long-term benefit of drug product programs • Led strategic efforts to optimize the drug product manufacture to meet clients’ supply needs • Led cross functional groups to ensure the successful operations to meet clinical and commercial needs • Identified key metrics to gauge operational successes • Communicated progress to clients to ensure manufacture met clients’ needs • Adhered to clinical and commercial regulatory guidelines to ensure the manufacture of safe and effective drug products
• Provided technical leadership to cross functional groups to ensure no impact to drug product quality • Owned manufacturing, facilities, and validation sections of BLA in support of regulatory filing of multiple Amgen products • Reviewed and approved technical documents used both at contract manufacturing sites and internal manufacturing sites
• Owned process characterization studies, leading to implementation of process parameter ranges for commercial unit operations • Contributed to commercial process development, PPQ, tech transfer, and BLA filing of Amgen drug products
• Owned process characterization studies, leading to implementation of process parameter ranges for commercial unit operations • Contributed to commercial process development, PPQ, tech transfer, and BLA filing of Amgen drug products