Bulk Drug Substance Process Hygiene Lead

Bulk Drug Substance Process Hygiene Lead

Join to apply for the Bulk Drug Substance Process Hygiene Lead role at Abb Vie

This range is provided by Abb Vie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

Job Description

The Global Bulk Drug Substance (BDS) Process Hygiene Technical Lead plays a critical role in ensuring process hygiene excellence across Abb Vie’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.

Responsibilities:

• Provide global oversight of process hygiene performance and manage hygiene-related risks across multiple BDS manufacturing sites and regions.
• 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’s 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.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.