Director/Senior Director, CMC Validation

Apply Job Type Full-time Description Position Title : Director/Senior Director, CMC Validation Reports to : Vice President, Chemistry, Manufacturing, & Controls (CMC) Location : Remote work, US Only Why Sabin: Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership, and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate. Position Summary: 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, which are produced at C(D)MOs globally. 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, as applicable. The role is accountable for designing, hiring, and leading a right-sized validation organization. This position will partner closely across CMC and 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. The successful candidate will bring deep expertise in biologics or viral vaccine validation, strong CMO governance experience, and the technical leadership needed to influence internal and external stakeholders in a fast-paced, late-stage environment. This role will also support future funding initiatives and enable technology transfers to alternate manufacturers. Key Responsibilities: Work across CMC and with Quality Assurance to define Sabin’s validation strategy from process characterization through PPQ, ensuring compliance with FDA and ICH guidelines and applicable GMPs (21 CFR Parts 210, 211, 600-610; EU Annex 1, Annex 15; ICH Q10). Create and support implementation of a risk-based validation program for Sabin, including establishing tools such as FMEA, risk registers, and CPP/CQA/KPP maps to prioritize and justify validation activities in conjunction with Sabin and C(D)MO SMEs. Design, author, and own Validation Master Plans for Sabin’s vaccines, covering upstream, downstream, fill/finish, analytical tests, and shipping activities across the C(D)MOs. In partnership with SMEs at Sabin and C(D)MOs, define PPQ protocol requirements, including batch selection rationale, acceptance criteria, sampling plans, and statistical approaches for demonstrating process consistency, ensuring that process characterization data packages adequately support PPQ parameter justification. Work with Portfolio and Program management to map validation activities into existing program timelines and agreed milestones. Serve as the primary validation interface with C(D)MOs, ensuring validation readiness, providing technical direction, undertaking document review and approval, and deviation support. Lead risk assessments to proactively identify potential risks and develop mitigation strategies for at-risk validation activities; proactively communicate risks. Work with other leaders in CMC to establish robust and comprehensive C(D)MO oversight aligned with contract and Quality Agreement obligations. Prepare relevant validation sections of regulatory filings (BLA, IND, MAA, CTA, etc.) and review submissions, as required. Partner with Analytical Development SMEs to develop compliant, robust and holistic analytical validation program. Partner with Quality Assurance to ensure compliant and robust facility and equipment validations (Stage 2A) are performed at manufacturing facilities. Lead and drive shipping validation activities for Drug Substance, Drug Product, and sample shipments, including completion of route risk assessments, protocol and report authoring, and identification and selection of vendors to perform studies. Serve as Sabin Validation SME during FDA and EMA inspections and agency meetings, as required. Experience leading in a matrixed environment; build and lead a high-performing matrixed validation team by partnering and creating strong relationships within Sabin and across external partners. Championing a culture of quality and continuous improvement, implement lessons learned, and share best practices across the C(D)MO network. 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. Other: Subject to a criminal background investigation Request for three professional references Verification of education/degrees Sabin’s philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $190,000 -$225,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs. Sabin provides a comprehensive benefits package that includes medical, dental, and vision coverage, as well as flexible spending accounts. Eligible employees receive flexible vacation and sick leave, along with employer-paid life and disability insurance. The organization observes 11 federal holidays and an end-of-year winter break. Sabin also offers an employer-matching 401(k) plan. Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws. Salary Description $190,000 -$225,000