Amy Wong

WORK HISTORY

EDUCATION

ABOUT AMY WONG

Email: a•••••@hotmail.comDedicated, resourceful, and collaborative professional with experience implementing and coordinating CMC activities, introducing process improvements, and strengthening relationships at all levels of the organization and between CMOs and internal cross-functional teams.Supported gene and cell therapies, antibody, protein, peptide, vaccine, small molecule, extended/controlled-release, powder, and lyophilized formulations, parenteral and oral dosage forms, topicals and transdermal patches.CORE COMPETENCIES: Hands-on drug development experience• Project coordination• Outsourced manufacturing/testing• Stability/reference standard program coordination• Formulation, process development/transfer• Analytical methods development/validation• Compliance auditing• Labeling/packaging/clinical supply chain• Protocol/report development• Regulatory submissions• Shipping coordinationACCOMPLISHMENTS:• Led activities with CMOs/cross-functional stakeholders to coordinate successful technical site visits.• Launched SharePoint site as single point of reference to department projects information.• Coordinated aggressive material sourcing/preparation/testing/shipping of formulations to enable on-time start of toxicology studies.• Defined and executed comprehensive strategy for extractables and leachables for BLA.• Designed/templated stability protocols; created master stability schedules.• Statistically trended stability data to extend expiry, saving ~6mos and $2Mil each time.• Revamped stability chamber calibration/qualification process; eliminate 100% of false alarms.• Hosted QA/client audits of stability areas with zero findings.• Established excellent rapport with contractors; successfully negotiated ~35% annual savings.• Initiated test report forms; adopted company-wide.• Simplified formulation process to platform, ensured homogeneity/stability/scalability.• Established labeling/packaging/clinical supply chain process (no prior experience) in ~1 month.