Jeffrey C. Mocny
Scientific Leader, Regulatory @Abzena
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WORK HISTORY
Scientific Leader, Regulatory @Abzena
Led early stage biological asset regulatory strategic and development planning to set Clients up for development and regulatory success through SOW delineation of deliverables with program objectives and regulatory strategy.Collaborated with BD, proposal writing, Abzena site leadership and technical leadership to re-develop Abzena SOW format, content and sales process. Contributed to and developed novel thought leadership publications and platform presentations to generate additional sales interest.Identified workflow gaps and led solution building teams in scientific transfer activities, regulatory compliance and new services serving as counsel to Chief Technical, Chief Scientific and Quality Site Heads.Streamlined platform manufacturing and analytical approaches for IgG1 molecules resulting in reduction in timeline and internal cost. Productized, built writing team and implemented regulatory writing services workflow for Clients needing Module 3 eCTD support by streamlining data flow, data verification and leading package drafting. Augmented biological product development scientific strategy with regulatory strategic guidance to speed programs to IND by coupling product functional attributes, unmet medical need market assessment and regulatory filing strategic insight. Collaborated with other Scientific Leaders to devise and implement LabZient (TM), an ICH Q14 based \"direct to QC\" analytical strategy by establishing Abzena \"Compendial Methods\" and Analytical Target Profiles for molecules. Working closely with QA, identified process gaps and developed solutions to maintain regulatory compliance standards for biological drug development at San Diego and Bristol Abzena sites. Drafted Site Master File preparation for Sanford, NC manufacturing site sale to PfizerOne.
EDUCATION
University at Buffalo
Doctor of Philosophy - PhD, Microbiology and Immunology
Gannon University
Master of Science - MS, Environmental Science and Engineering
Gannon University
Bachelor of Science - BS, Biology
SKILLS
ABOUT JEFFREY C. MOCNY
Product Strategy & Development Executive Leader leveraging extensive experience in…
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