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.
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.