Senior Director, MSAT

Own the global technical strategy and optimization of aseptic DP operations across container types (vials, pre-filled syringes, devices).,Oversee product lifecycle and Continued Process Verification (CPV), driving robust risk management and mitigation planning.,Introduce enabling technologies such as closed systems, single-use platforms, and advanced sensors/PAT.,Embed digital and AI solutions in DP operations, especially automated visual inspection.,Provide real-time and remote technical support for deviation investigations, root cause analysis, and CAPA implementation.,Serve as SME during global health authority inspections and contribute to CMC dossiers and responses.,Define and deploy network-level data and master standards for interoperability across MES, LIMS, QMS, and historian systems.,Use AI/ML and statistical tools for multivariate analysis and anomaly detection.,Establish standardized philosophies for visual inspection (manual, semi-automated, automated), including algorithm validation.,Lead optimization of labeling and packaging operations, ensuring serialization, traceability, and cold chain compliance.,Build and lead a world-class DP MSAT team with clear development plans, technical decision-making guidance, and inspection preparation.,Harmonize global procedures and standards across internal and external manufacturing sites.,Drive annual productivity targets in partnership with Supply and Finance.,Ensure compliance with particle/defect detection standards and AQL sampling protocols.,Lead deployment of CPV dashboards, automated alerts, and self-service analytical capabilities.,Promote a psychologically safe, inclusive environment.,Travel >40% of the time.

Technical Expertise: Filling process development, optimization, and validation; Visual inspection technologies (manual and robotic); Process validation, EMPQ, and media fills; Regulatory compliance and contributions to PPQ and BLA filings; Familiarity with global regulatory guidelines (CFR 21, ICH, PDA standards); Proficiency in Continued Process Verification (CPV), Quality by Design (QbD), and data analytics tools; Familiarity with labeling and packaging processes.,Intellectual curiosity and ability to lead and mentor staff in technical areas outside your area of expertise. Ability to influence cross functionally.,Demonstrated experience implementing new technology for commercial operations.,Strong technical problem-solving experience.

M.S. or Ph.D. in a technical discipline (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.)

Must be willing to travel (>40% of the time); Position may involve access to U.S. export control laws (only U.S. persons are eligible).