The Global Bulk Drug Substance (BDS) Process Hygiene Technical Lead plays a critical role in ensuring process hygiene excellence across AbbVie’s global BDS manufacturing network. This is a cross-functional leadership role that requires a deep understanding of BDS manufacturing, and the ability to influence global site stakeholders and leadership. The Global BDS leads role is to improve and maintain a best-in-class global Process Hygiene Index across AbbVie’s BDS network and standardize long-term procedural and technical solutions to mitigate hygiene risks across all global BDS sites.

Responsibilities:

•Provide global oversight of process hygiene performance and manage hygiene-related risks across multiple BDS manufacturing sites and regions, including but not limited to: Cell culture inoculation, production bioreactors, chromatography, ultrafiltration, and bulk fill.
•Lead a global Center of Excellence (CoE) for BDS process hygiene, focusing on risk awareness, procedural excellence, and technical innovation.
•Assess shop floor operations and FUE (Facility, Utility, and Equipment) design to identify process hygiene risks.
•Recommend and drive procedural updates and documentation governance aligned with hygiene best practices.
•Identify and champion innovative technical solutions to mitigate hygiene risk and standardize successful approaches network-wide.
•Collaborate with Global and Site Engineering to drive capital improvement initiatives.
•Influence annual Capital Planning and Long-Range Capital Planning processes by integrating hygiene-driven project needs.
•Lead or support investigation of hygiene-related events; drive root cause analysis and implement corrective actions.
•Develop and maintain analytical tools to report and track global process hygiene metrics.
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