PROFESSIONAL EXPERIENCE

CMC AND QUALITY EXPERIENCE
 Created and managed the implementation of integrated CMC and QC/QA activities, including development and manufacturing of API and Drug Product; development and validation/qualification of analytical assays; design and monitor of comparability and compatibility studies.
 Established acceptance criteria for API and Drug Product for preclinical and clinical use in accordance with FDA requirements of drug safety and approved final release of API and Drug Product.
 Reviewed the CMC/CRO documentations, including SOPs, Protocols, ATMs, MBRs, Test Records, etc.
 Reviewed analytical test results and production batch records for accuracy and compliance with FDA regulations.
 Maintained up-to-date information on the status of all ongoing CMC activities, identified and monitored critical path activities, performed troubleshooting and provided recommendations/solutions for critical issues.
 Prepared documentation for an internal QC/QA department, including writing SOP and summary reports.
PROTEIN CHEMISTRY (DEVELOPMENT, MANUFACTURING AND ANALYTICAL TESTING)
 Excellent knowledge of state of the art protein and antibody development and manufacturing, designing a scalable and robust production process with high yields.
 Experienced in scaling up of protein and antibody production from mg to kg scale for both upstream and downstream processing.
 Cell line development and optimization.
 Excellent understanding regulatory and ISO standards for manufacturing of protein, monoclonal and polyclonal antibodies, including control of critical steps and safety.
 Excellent knowledge of protein purification techniques including all types of chromatography, clarification and UF/DF filtration techniques.
 Expression and purification of proteins from different expression systems including CHO cells, E. coli and baculovirus.
 Solid knowledge of analytical assays for ***** logics including HPLC, SDS-PAGE, CE, ELISA, IEF, Western Blot, cell-based and enzymatic ***** logical activity assays, etc..
 Highly proficient in assay design and optimization, results analysis, interpretation and troubleshooting.
 Experienced structural characterization of proteins and antibodies by LC-MS analysis, AAA, peptide mapping, S-S bond analysis, glycoprofiling, monosaccharide analysis, sialic acid content, ultracentrifugation, etc.
 Understanding of regulatory requirements for release and stability testing, assay validation, qualification and transfer.
FORMULATION AND STABILITY
 Conduct ICH stability and photo stability studies to assure sufficient shelf life and proper storage of an API/DP.
 Designed and monitored formulation and accelerated stability studies.
 Preformulation stability study, methods selection, design and results analysis including CD and SIC.
 Developed formulation for therapeutic antibody (oncology and AMD) with protein concentration of 100 mg/mL.
REGULATORY
 Excellent knowledge regulatory requirements for ***** logics.
 Preparation of documentation for FDA filing via electronic submission; communication with FDA.
 Authored CMC sections for initial, serial and annual (DSUR) regulatory submissions.
 Cycle management of CMC submissions.
 GMP and vendor qualification audits of CRO, CMO and CTO.
LEADERSHIP AND MANAGEMENT/PROJECT MANAGEMENT EXPERIENCE
 Over nine years of supervisory/management experience; established and ran three protein chemistry labs; excellent knowledge of lab organization and day-to-day operations.
 Managing day-to-day activities of direct reports, conducting performance evaluation and preparation of tracking reports for an upper management.
 CMC leadership, business strategy, development, planning and budgeting.
 CMC project management, selection, interaction, coordinating efforts and managing of external contract organizations for establishing their scope of work and timely delivery of project milestones.
 Setting up and leading on-site meeting and teleconferences preparing agendas and minutes, tracking goals and action items, writing tracking, development and final reports to the upper management.
 Preparation of publications, memos, summary reports, SOP, test records, etc.
 Presentations to upper management and corporate partner. Participation in the inter-department teams.
 Introduction of new products to support product niches including signal transduction, glyco ***** logy and proteomics. Hands-on developed about 25 new products and participated extensively in developing of the EMD ***** sciences protein group portfolio (over 100 products).
 Excellent, organization, coaching, conflict resolution and problem solving skills.
 Proven capability in multitasking and troubleshooting of projects and instruments.
 Excellent oral and written communication skills.