Director/Senior Director, CMC Validation

• 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.

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, Power Point, Word), and Adobe Acrobat.
• Up to 20% travel within the United States and Europe to support validation activities.
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