Biopharmaceutical professional of over 20 years with demonstrated capability across broad areas of CMC functions, specialized in cGMP analytical methods, technology transfer and CRO/CSP management. Over 15+ years of QC and technical operations management including compliant labs, quality systems, robust stability program, global reference standard and critical reagent program. Expertise in bioanalysis of small molecule, protein, mAb, vaccine products and biomarker for PK/PD, release, stability and product characterization studies. CMC support for IND, NDA and BLA submissions. Expertise in cGMP method validation for product/process/equipment/facility and systems. Contributed to success of commercial programs of anthrax vaccine and Erbitux; multiple oncology mAb products including cancer immunotherapy product Keytruda®. Depth in diverse areas of structure-function and applied studies on proteins. Enterprise focused leader of high quality results and project deliverables with team work and collaboration. Strategic and motivational leader committed to build high-performance teams with mentoring and coaching. Thorough understanding of regulatory guidelines, operational excellence, continuous process and performance improvements. Detail oriented, adept in written, verbal and interpersonal communication, and business savvy public speaking. Creation and setting-up of new functional biophysical and immunochemistry labs.
GOALS: Work for companies and organization engaged in innovation and problem solving in vast areas of pharmaceutical development for human needs.
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