Associate Director, Process Validation

Role Overview

• Provide strategic and scientific leadership for process validation (PPQ, CPV, lifecycle validation) across commercial programs.
• Lead and facilitate execution of validation strategies to support technology transfer, site readiness, and product launch.
• Ensure alignment of validation activities with regulatory expectations and lifecycle management plans.
• Develop and implement risk management frameworks, tools, and processes in collaboration with Quality.
• Lead cross-functional risk assessments to identify, evaluate, and mitigate operational, technical, and regulatory risks.
• Monitor and communicate risk trends and key risk indicators to stakeholders.
• Support commercial manufacturing operations by ensuring processes remain in a validated and controlled state.
• Contribute to lifecycle management activities, including process improvements and continued process verification.
• Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, and Engineering to support commercialization and supply continuity.
• Partner with internal teams and external CMOs to ensure alignment on validation and risk strategies.
• Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization.
• Support deviation investigations, ensuring timely resolution and sustained compliance.
• Contribute to authoring and reviewing regulatory filings and responses to health authorities.
• Effectively communicate the scientific and commercial rationale for validation and risk management strategies.
• Provide leadership for execution of process validation and comparability activities, ensuring data integrity and compliance.
• Provide guidance on raw material qualification strategies to ensure supply reliability.
• Support validation activities across internal and external manufacturing networks.
• Communicate process validation performance and risk insights to key stakeholders.
• Build strong working relationships and influence across a matrixed organization.
• Contribute as a key member of the Global MSAT organization to enable successful commercialization.

Requirements

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A.
• Strong experience in biologics/vaccine manufacturing, including:
• Process validation (PPQ/CPV)
• MSAT, technical operations, or late-stage development
• Technology transfer and commercialization
• Experience in quality risk management (ICH Q9) and regulatory expectations
• Demonstrated leadership in matrixed or cross-functional team environments
• Ability to apply deep technical knowledge to develop strategies and drive execution
• Strong problem-solving, organizational, and strategic planning skills
• Excellent communication and stakeholder engagement skills
• Ability to analyze data and align stakeholders with organizational strategy
• Innovative and entrepreneurial mindset to drive continuous improvement
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

Benefits

• The compensation package will be competitive and includes comprehensive benefits and an equity component.