Director/Senior Director, CMC Validation

🕒 2 days ago

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Sabin Vaccine Institute

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

⚕️ Healthcare Insurance

🧬 Biotechnology

🤝 Non-profit

💰 $35M Grant on 2023-01

Healthcare Insurance • Biotechnology • Non-profit

Sabin Vaccine Institute is dedicated to improving global health by ensuring access to life-saving vaccines. The institute focuses on research and development of new vaccines for some of the world’s most pressing diseases, including cholera, HPV, malaria, Marburg, and Ebola. Through innovative programs and partnerships, Sabin aims to enhance immunization capacities and vaccine acceptance within communities, ultimately striving to make vaccination accessible to all, especially vulnerable populations.

📋 Description

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

🏖️ Benefits

• medical, dental, and vision coverage • flexible spending accounts • flexible vacation and sick leave • employer-paid life and disability insurance • 11 federal holidays • end-of-year winter break • employer-matching 401(k) plan