Bulk Drug Substance Process Hygiene Lead

Global Bulk Drug Substance (BDS) Process Hygiene Technical Lead

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.

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.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie 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.