Director/Senior Director, CMC Validation

About the role

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.

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.

Qualifications

• 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).
• Educational requirements: Bachelor’s degree in biochemistry, chemistry, biology, chemical engineering, or a related pharmaceutical science required; advanced degree strongly preferred.

Skills

• Strong technical writing skills.
• Effective communication and presentation skills.
• Organizational and detail-oriented skills.
• Interpersonal and relationship-building skills.
• Proficiency with Microsoft Office applications and Adobe Acrobat.

Benefits

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.