AES cmo Leadership Team
Margaret Ogiela
Sr. Director of Contract Operations
Margaret brings over 20 years of experience in pharmaceutical and biotechnology manufacturing, with deep expertise across aseptic drug product fill-finish, sterile manufacturing, medical device production, and end-to-end CMO project management. This end-to-end visibility directly strengthens AES’ Biologics ability to execute reliable tech transfers and prepare processes for GMP readiness with fewer gaps and faster timelines. Her background spans R&D, process development, clinical supply, and commercial distribution — giving her a uniquely comprehensive understanding of the full product lifecycle within a contract manufacturing environment.
Throughout her career in biopharma CMOs, Margaret has been the primary client interface, driving execution of complex clinical and commercial programs while overseeing a high-value portfolio representing up to 40% of annual company revenue. She has led cross-functional readiness across quality, manufacturing, and supply chain, negotiated contracts, built estimating tools, and advanced products from tech transfer through FDA approval and U.S. commercial launch, while expanding contract scope to improve profitability
Margaret’s experience includes tech transfer from R&D through process development into GMP manufacturing, ensuring processes, documentation, and materials are ready for execution with compliance to QSR, cGMP, EU, and ISO standards. This depth of hands-on tech transfer expertise directly supports AES Biologic’s differentiated approach—enabling faster, more efficient transfers that reduce execution risk, shorten timelines, and improve first-time success for clients. She has led teams through FDA, ISO, and client audits; managed CAPAs, deviations, and risk evaluations; and accelerated multiple mission-critical manufacturing campaigns — including rescuing a client product under clinical hold and delivering replacement supply in under three months.
Known for her operational discipline, Margaret has established new lab functions, trained project managers, and built cross-functional collaboration frameworks that integrate quality, production, engineering, and business development. Her leadership consistently improves project visibility, resource planning, budget accuracy, and schedule adherence — all core capabilities required for CMO operational excellence.
At AES, Margaret strengthens program execution, client communication, and operational alignment across the organization. Her background ensures AES biologics to deliver schedule-driven execution, reliable tech transfers, and compliant program management, all essential for clinical stage biologics development.



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