Bulk Drug Substance Process Hygiene Lead

Role Summary

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 cross-functional leadership role requires a deep understanding of BDS manufacturing and the ability to influence global site stakeholders and leadership. The role aims 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.

Qualifications

• Education: Bachelor‚Äôs degree in a technical discipline e.g., Chemical Engineering, Microbiology, Bioengineering, or similar discipline.
• Experience: Minimum of 7 years in BDS manufacturing, with demonstrated expertise in upstream and downstream operations.
• Strong knowledge of GMP requirements and cross-functional roles in technical operations, documentation, and quality systems.
• Proven track record in technical problem-solving, risk assessment, and hygiene-related process improvements.
• Experience with capital and operational budgeting, particularly with respect to hygiene risk mitigation and single-use systems.
• Exceptional communication skills, with the ability to influence and lead across multiple functions and global sites.
• Demonstrated ability to prioritize and escalate competing demands effectively to site and network leadership.
• Deep understanding of shop floor operations and technical systems within BDS manufacturing.