Virginia Muniz, Ph.D., PMP

Lead CMC program execution and CDMO coordination for a late-stage, allogeneic cell therapy advancing through Phase 3 toward commercialization. Serve as the primary liaison to external manufacturing partners, driving integrated timelines, governance, risk management, and cross-functional alignment across Process Development, Manufacturing, Quality, Regulatory, and Supply Chain. Own CMC project planning, dashboards, and documentation while ensuring disciplined execution against scope, budget, and regulatory expectations. Partner closely with internal leaders and external stakeholders to resolve issues, strengthen communication, and support readiness for pivotal trials and future approval.

Led enterprise-level CMC programs supporting late-stage and commercial biologics, managing budgets and cross-functional teams. • Served as primary liaison between technical functions, facilitating cross-departmental alignment and securing senior leadership approval for program decisions. • Implemented project tracking dashboards and knowledge-sharing platforms, reducing reporting errors and accelerating issue resolution across teams. • Identified and proactively managed risks and resource constraints, resolving complex issues to align teams on integrated CMC strategy. • Maintained professional stakeholder communications, advancing program goals and driving executive-level engagement. • Guided critical due diligence for an acquisition, led technical assessments and integration planning across CMC functions, and ensured a smooth transition and successful integration of Decibel’s AAV programs (DB-OTO and GJB2).

Managed end-to-end upstream and downstream technology transfers, coordinating with internal teams and external partners (Bayer, Roche) to ensure regulatory compliance and process readiness. • Led upstream and downstream technology transfer activities, ensuring timely execution of deliverables. • Generated and reviewed transfer proposals, process descriptions, raw material gap analyses, and regulatory documentation. • Supervised junior team members and interns, instilling best practices and lessons learned to optimize transfer processes. • Spearheaded raw material readiness initiatives, supporting qualification and implementation of alternates. • Facilitated investigations and managed document exchange/approval during transfer, ensuring timely project execution.

Supported technology transfer activities for clinical and commercial biologics, coordinating documentation, partner communication, and regulatory submissions. • Authored transfer proposals and documentation supporting successful external collaborations. • Guided raw material qualification and implemented risk-based improvements, enhancing transfer process efficiency. • Contributed to regulatory filings and investigations, supporting inspection readiness.

Provided technical support for commercial and late-phase clinical manufacturing of biologics, ensuring GMP compliance and process efficiency. • Authored technical evaluations for regulatory filings, supporting successful inspection outcomes and program approvals. • Assisted in investigations, validation reports, and SOP creation, ensuring compliance with cGMP standards. • Evaluated manufacturing requirements prior to process transfers, supporting smooth handoffs and operational readiness.