We are a community of biopharma professionals passionately engaged in the development and commercialization of novel therapeutic solutions for patients. Our purpose is to discover best practices from the shared insights of our members. Our aim is to help our members become strategic leaders and drivers of business outcomes within their organizations.

Lead and manage multi-disciplinary teams in the successful delivery of finished drug products for regulatory submission and commercialization. Work with project leads of API (drug substance manufacture or supply), formulated production (drug product), Regulatory Affairs (compilation and submissions), Clinical (Biostudy and GCP) and Commercial (initial launch and supply to market). Responsible for implementing product project scope in a timely manner, ensuring cost and quality objectives are met and the project is delivered on time.

Worked closely with Quantic to ensure timle review of bach records. Implemented processes to ensure appropriate remediation to meet consent decree requirements.

Shepherd drug candidates through development pipeline. Work closely with Program Executive and respective sub-team leads to advance drug development programs. Lead candidates target longer acting treatments of Hemophilia B (FIXFc) and Hemophilia A (FVIIIFc), in Phase I/II/III and Phase I respectively. Additionally support a peptide program in pre-clinical stage targeting auto-immune diseases. Key responsibilities and accomplishments include:• Build and maintain comprehensive program schedules for drug candidates. Develop customized schedules to facilitate effective planning and alignment (e.g. regulatory filings; initiating clinical trials, etc.)• Ensure effective relations with Biovitrum, co-developer based in Sweden for lead hemophilia programs• Drafted integrated development plans for both hemophilia programs and CMC development plans for FIXFc program to document and align team strategy.• Support US and international regulatory filings; to advance global clinical program.• Ensure timely resolution of key issues with senior stakeholder awareness and input• Contribute to strategic decisions and program direction• Facilitate and administer Core Team and sub-team meetings; develop agendas, prepare minutes, track actions, etc.• Developed and manage competitive landscape to keep stakeholders and core team abreast of commercial intelligence in hemophilia market.

Supported commercial manufacture of Herceptin in Wyeth's role as a contract manufacturer for Genentech.• Core Project member for tech transfer team. Facilitated Joint Project Sub-teams (Quality, QC, Engineering, Technology, and Supply Chain). Implemented Risk Management Program. Managed multiple ad hoc initiatives to resolve issues and ensure timely results. Received FDA approval within two years after signing contract!• Served as liaison with Genentech in on-going operations. Authored Joint Services Agreement to define working relations through contract execution.• Managed Compliance Coordinators to conduct investigations, perform suite walkthroughs, and lead initiatives to ensure compliant operations. • Support Executive Steering Committee, and Technical Operations Committee facilitating appropriate communications and reports for relevant stakeholders.

Managed multiple efforts for the Network (Global) Quality Unit supporting all BioPharma sites: Andover, MA; Grange Castle, Ireland; St. Louis, MO. • Central liaison to establish Grange Castle’s Quality Unit. Developed charter and project plan; managed monthly Quality forums, provided direction for new personnel, facilitated planning sessions, and led staff meetings until Quality team was in place.• Established program to effectively contribute in Wyeth’s Sustainable Compliance Initiative to develop Wyeth-wide standards governing GMP quality systems (e.g. Investigations, Change Control, Tech Transfer, etc.). Managed development teams for Conformance Standards; led management meetings, and chaired oversight council. • Facilitated Quality Partnership between Wyeth Europa and Wyeth BioPharma to ensure effective relations to appropriately support BioPharma products in Europe. • Contributed to numerous multi-site initiatives including the BioPharma Compliance Council, Multi-site GMP Documentation, BSE/TSE Advisory Group, Training, etc.

Central contact and initiate for cross-institutional initiatives between eleven premier colleges and universities to pursue mutual learning / cost containment opportunities. • Developed two web-based training programs addressing OSHA and EPA requirements• Established “Preferred vendor” IT Training relationships realizing over $100k savings• Executed two technical job fairs, resulting in numerous hires for member schools.• Supported two retreats strengthening the Consortium’s community and collaboration.

Conducted numerous research projects and surveys for published articles and reports.