Director/Senior Director, CMC Validation

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Requirements • Bachelor’s degree in biochemistry, chemistry, biology, chemical engineering, or a related pharmaceutical science required; advanced degree strongly preferred. • Minimum of 12+ years of experience with GMP validation in biologics, vaccines, or gene/cell therapy, with at least 5 years in a leadership role; Senior Director candidates require 14+ years of experience. • Demonstrated track record of building or significantly expanding validation programs, ideally through PPQ/BLA. • Experience managing CMO/CDMO validation activities for late‑stage and commercial products, including oversight of external partners in a remote environment. • Deep knowledge of FDA Process Validation Guidance (2011), ICH Q8–Q10, 21 CFR 210/211, and EU Annex 15 requirements. • Experience authoring or contributing to BLA or MAA submissions, specifically process validation and manufacturing sections. • Familiarity with WHO/CEPI vaccine manufacturing standards. • Experience with FDA pre‑approval inspections (PAIs) or EMA GMP inspections as validation SME. • Exceptional technical writing skills; able to author clear, inspection‑ready validation documents. • Strong influencing and negotiation skills for managing external CMO partners without direct authority. • Proficiency with risk management tools (ICH Q9, FMEA, criticality assessments) and statistical methods for validation (ANOVA, process capability, sampling plans). • Effective communicator with experience presenting to senior leadership, regulatory agencies, and cross‑functional teams. • Organized, detail‑oriented, and able to manage multiple parallel workstreams across different CMO sites and time zones. • Strong interpersonal and relationship‑building skills, with a demonstrated ability to collaborate effectively across teams. • Proficient in Microsoft Office applications (Excel, Outlook, PowerPoint, Word), and Adobe Acrobat. • Up to 20% travel within the United States and Europe to support validation activities.

Overview • The Director/Senior Director, CMC Validation reports to the Vice President, Chemistry, Manufacturing, & Controls (CMC) and is a strategic, hands‑on leader responsible for building and implementing a comprehensive validation program for Sabin’s vaccines. • This individual will build Sabin’s validation strategy from the ground up and implement it across the network. • Responsibilities include authoring validation policies, procedures, templates, and related documentation; overseeing validation activities at C(D)MOs; and driving the organization to Process Performance Qualification (PPQ) readiness in alignment with FDA, EMA, WHO, and ICH expectations. • The role is accountable for designing, hiring, and leading a right‑sized validation organization. • This position will partner closely across CMC, with Program & Portfolio Management, Quality Assurance, C(D)MOs, and other stakeholders to ensure validation requirements are fulfilled in a smart, risk‑based manner, ultimately delivering submission‑ready data packages. • The Director/Senior Director, CMC Validation serves as a validation subject‑matter expert (SME) with demonstrated experience building and implementing validation programs for late‑phase assets. • This role will also support future funding initiatives and enable technology transfers to alternate manufacturers.