Sr. Director, Aseptic Process & Design
Core
Define and govern enterprise-wide aseptic process standards, contamination control strategies, and risk frameworks for sterile manufacturing sites.
Role type
Sr. Director, Aseptic Process & Design (Strategy & Standards)
Builds
Enterprise sterility assurance frameworks, contamination control strategies, and regulatory-ready technical documentation for global manufacturing.
Domain
Pharmaceutical manufacturing (sterile biologics/drug products)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (sterile manufacturing systems & standards)
Required skills
Aseptic process design, contamination control strategy (CCS), risk assessment (FMEA, fault tree), regulatory inspection support, hygienic equipment design, environmental monitoring, Single-Use Technologies (SUT) expertise, cross-functional leadership
Preferred skills
Advanced degree (M.S./Ph.D.), biologics manufacturing experience, complex drug product manufacturing
Technologies
EU GMP Annex 1, FDA Aseptic Processing Guidance, ICH Q9/Q10/Q11, USP <1116>/<797>, ASME BPE, EHEDG, APS/media fill systems, smoke visualization tools
Responsibilities
Define enterprise sterility and microbial failure mode libraries; establish contamination control strategy aligned with regulatory expectations; perform global microbial risk assessments; author technical Business Technical Assessments (BTAs); govern aseptic process simulation (APS) and media fill programs; define manufacturing process and equipment design standards for sterilization; oversee smoke study programs; lead by-design oversight for facility and capital projects; drive continuous improvement based on environmental monitoring trends.
Seniority
Senior, strategic leadership & cross-functional alignment
