Boston, Massachusetts, United States
• A biotechnology professional with 22 years of experience (11 years in managerial roles) in practicing current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) in compliance with the Code of Federal Regulations (CFR) Title 21 Part 11/210/211 and European Union (EU) GMP Annex, including 9 years of international experience in management roles for working with contract manufacturing organizations (CMOs) in Korea • Possession of successful records of managing and participating in regulatory agency inspections such as Pre-approval inspections (PAI)/Pre-license inspections (PLI)/GMP inspections conducted by the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) • Experience in development of clinical stage products leading to commercial launch as Quality, Manufacturing Operations and CMC (Chemistry, Manufacturing and Controls) for various biologics and small molecule product types (monoclonal antibody/ Escherichia coli fermentation/ microbiome and organic-synthesis-based small molecule) • Experience in working with the entire stages of cGMP aseptic manufacturing process covering from raw material receipt and inspection management, manufacturing, testing to final product disposition, in both clinical and commercial manufacturing environments under various production scales (from 25 L to 184000 L)
Responsible for making strategic Quality decisions related to microbiome-based internal manufacturing at the Cambridge and Acton sites (25 L and 200 L scale), external manufacturing at two CMO plants as well as finished product disposition decisions - Establish a new Quality Operations team overseeing GMP manufacturing and product disposition for four (4) microbiome-based programs in various clinical stages (one in phase III, one in phase II and two in phase I) - Strategically manage QA Operations resources for prompt review of manufacturing batch records, Certificate of Analysis (CoA), deviations, change controls, Corrective and Preventive Actions (CAPA) and Out-of-Specification (OOS) to ensure product supply for clinical stage programs - Final disposition decisions of Cell Banks, Drug Substances, Drug Products, Finished Drug Products, Final Drug Kits, and Placebo from internal and contract manufacturing sites - Coordinate with Qualified Person (QP) for release of products and kits to clinical trial sites in European countries
Person-in-Plant (PIP) - stationed mostly in Korea overseeing quality operations as well as clinical and commercial manufacturing operations at two contract manufacturing organization (CMO) sites manufacturing a biologics drug substance and a small molecule drug substance for Spectrum Pharmaceuticals. Provided Good Manufacturing Practice (GMP) guidelines and training including principles of deviation investigation and inspection preparation to the members working at the CMO sites as they are preparing for FDA pre-approval inspections.
Person-in-Plant (PIP) - stationed mostly in Korea overseeing clinical and commercial manufacturing operations at two contract manufacturing organization (CMO) sites manufacturing a biologics drug substance and a small molecule drug substance for Spectrum Pharmaceuticals. Provided Good Manufacturing Practice (GMP) guidelines and training (including principles of deviation investigation and inspection preparation) to the members working at the CMO sites as they are preparing for FDA pre-approval inspections.
Joined a foreign start-up contract manufacturing organization (CMO) manufacturing biologics drug substances and built a deviation managing quality system that passed pre-license inspections and annual Good Manufacturing Practice (GMP) inspections conducted by FDA and EMA. Performed duties (summarized below) to ensure the quality and manufacturing operations at the site are in compliance with FDA and EMA regulations. • Managed Deviation team to ensure deviation and , Out of Specification (OOS) investigations are completed meeting the expectations from FDA and EMA regulations • Provided review of minor/major deviation investigations and CAPAs prior to client review and final QA review • Reported trends, risk assessment outcome, and critical issues to QA management and all respective clients • Identified deviation trends in quality issues and collaborates with company management to ensure that risk-managed solutions are implemented in a timely fashion • Developed training curriculum for Deviation/CAPA Reviewers as well as new employees. • Managed the Deviation and CAPA Management system • Supported Electronic Quality Management System (EQMS) related activities including user account management and improvements/validations • Provided periodic reports to site management • Served as a Subject Matter Expert of Deviation Management system for FDA and EMA inspections • Provided support to ensure all manufacturing operations are executed in compliance with approved procedures
Managing Bills of Materials and Product Specifications Plant Complaint Coordinator