Lilian A.

Provides global strategic project management for multiple biologics programs, coordinating cross-functional CMC activities from clinical through commercial stages, including R&D, manufacturing, testing, supply chain, and regulatory submissions. Leads multi-site operations strategy execution, technology transfers, and risk mitigation to ensure on-time, compliant milestone delivery across international manufacturing networks. Leverages advanced project management, data, and AI tools to optimize workflows, enhance visibility, and support informed decision-making, while partnering closely with cross-functional leaders and governance teams to align execution with overall biologics strategy.

Developed and implemented enterprise-wide project and change management frameworks to strengthen governance, standardize execution, and improve consistency across global operations. Partnered with cross-functional teams and senior stakeholders to align priorities through OKR tracking, facilitate operational reviews, and provide PMO leadership and on-demand support for high-priority initiatives. Enhanced organizational effectiveness by delivering PM training and documentation, optimizing PMO systems and SharePoint resources, and enabling proactive manufacturing readiness through integrated planning and risk mitigation.

▪​ Supported enterprise project management activities across manufacturing, engineering, and supply chain functions. ▪​ Developed and maintained project plans, schedules, and governance tracking tools. ▪​ Monitored project progress, risks, and deliverables, escalating issues as needed. ▪​ Facilitated cross-functional meetings to ensure alignment on timelines and priorities. ▪​ Created project documentation, dashboards, and reporting materials for leadership updates.

Directed the planning and execution of clinical, and commercial biologics manufacturing projects, delivering on schedule, within budget, and in alignment with client and corporate objectives. Led cross-functional coordination across Client, Quality, Regulatory, and Analytical teams to meet contractual, regulatory, and client requirements while proactively managing risks and escalations. Oversaw project financials, documentation, and regulatory submission support, serving as a primary client interface to ensure transparency, compliance, and high levels of client satisfaction.

Built a strong foundation in regulated environments by supporting biologic and small-molecule programs as an analyst under cGMP/GLP conditions, contributing to stability, release, and regulatory submissions. Performed analytical testing (icIEF, CE-SDS, ELISA, HPLC-UV, UV/VIS) to evaluate protein therapeutics and synthetic drug products for purity, stability, identity, and quality. Partnered cross-functionally with Quality and Regulatory teams to author and review compliant documentation (e.g., IND-supporting materials, COAs, investigations, CAPAs), ensure data integrity and audit readiness, perform root-cause analyses, and drive continuous improvement—experience that informs effective risk management, quality oversight, and stakeholder collaboration in clinical project execution.

Experienced pharmacy professional with a strong record of accurately interpreting and processing high-volume electronic and handwritten prescriptions in full compliance with federal and multi-state (MN, IL, MO) regulations, including DEA, FDA, USP, and HIPAA standards. Demonstrated expertise in dispensing medications safely, compounding sterile and non-sterile preparations, managing complex third-party billing (commercial, Medicare/Medicaid, and workers’ compensation), and resolving insurance and prior-authorization issues to ensure timely patient access to care. Recognized for delivering high-quality customer service, mentoring and training pharmacy staff, and leveraging scheduling systems and basic data analytics to improve workflow efficiency, reduce errors, and support operational decision-making.

Supported analytical formulation and stability studies for vaccine candidates, generating high-quality data to assess product purity, stability, and potency under regulated laboratory conditions. Applied a broad range of analytical techniques and (SDS-PAGE, Karl Fischer, UV/VIS spectrophotometry, SEC-HPLC) and validated instrumentation while ensuring strict adherence to GMP/GLP and data integrity standards. Contributed to assay troubleshooting and continuous improvement by investigating deviations and implementing solutions to enhance method robustness and laboratory efficiency.

▪​ Supported project timelines for analytical studies and development programs. ▪​ Coordinated laboratory activities to ensure timely execution of study deliverables. ▪​ Reported progress updates and results to project stakeholders.