Sr. Director, Aseptic Operational Support
Core
Enterprise governance and leadership for aseptic operations, sterility assurance, and contamination control across global pharmaceutical manufacturing sites.
Role type
Senior Director, Aseptic Operational Support
Builds
Enterprise-wide policies, standards, performance monitoring strategies, and contamination event response frameworks for sterile and non-sterile manufacturing.
Domain
Pharmaceutical manufacturing (small molecule, biologics, cell/gene therapy) and regulatory compliance.
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> dashboards & analysis
Required skills
Enterprise strategy, aseptic science technical authority, contamination event leadership, environmental monitoring program design, CMO oversight, gowning and facility design guidance, regulatory inspection leadership, cross-functional change management, data fluency.
Preferred skills
Advanced degree in Microbiology or related field.
Technologies
None explicitly listed as tools/frameworks.
Responsibilities
Govern enterprise aseptic and microbial control practices; define enterprise KPIs and performance monitoring strategies; lead cross-site harmonization of aseptic practices; serve as technical authority for contamination events; define environmental monitoring program requirements; oversee CMO aseptic performance; provide guidance on gowning and facility design.
Seniority
Senior Director, enterprise-level strategy & mentorship
