Bio

Results-driven leader with technical, managerial, and executive experiences. Proven background in leading quality and technical functions within global operations. Key member of BMS Global Quality Leadership Team. Accomplished leader of industry quality-focused task forces to improve and standardize best practices. Breadth of exposure to various product types, including mAbs, ADCs, Coagulation Factors, ATMPs, Small Molecules, Biosimilars. Highlights • 20 years of management experience in the development and manufacture of commercial and clinical biologics. • Experienced in phase-appropriate quality systems, quality operations, QRM, CMC development, IND/BLA reviews. • Highly experienced in specification and limit setting, comparability protocols, process validation, technology transfer, OOS investigations, statistical analysis, lean implementation, and risk-based decision-making. • Experienced in managing regulatory inspections for US, EU, and ROW, and internal/external auditing. • Expert in QC testing, analytical method development, qualification, validation, transfer, reference/control and stability programs. • Excellent communication, training, coaching, and presentation skills. Accomplished PDA Task Force Leader for: • Analytical Method Validation and Transfers for Biologics (TR 57, 2010-15) • PCMO L01 for Biological Product IMP Specification Setting (2012-15) • Biosimilars Initiative (2015-19) • ANS-007 Standard Chair (since 2021) Current PDA Leadership: • PDA’s Board of Directors member (since 2019) • ATMP AB Chair (since 2020) • PDA Advisory Board member for BioAB (since 2014) and RAQAB liaison/member (since 2017). Awards/Recognition Received: • Winner of: PDA´s Distinguished Book Author Award (2008), • Fred Simon Award (2017), • Distinguished Service Award (2018), • Service Appreciation Award (2019), • Service Appreciation Award (2020), • PDA Letter Article of the Year (2021). [Only recipient of all three PDA publication awards] • Invited by FDA to represent an industry perspective to OBP/FDA Reviewer Staff for the analytical method lifecycle steps (2012) and for accelerated product development (2015). • Invited by Health Canada to represent an industry perspective and case studies to the agency to support the implementation of ICH Q2(R2), Q12 and Q14 (2021).