Technical Lead, External Drug Substance Manufacturing

AbbVie Inc.; North Chicago (IL); On-site; USD 160,000 - 230,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Job summary

AbbVie Inc. seeks a Technical Lead to oversee external manufacturing partners for drug substance and intermediates. You will ensure robust, compliant processes and deliver consistently high-quality product through cross-functional collaboration with Quality, Regulatory, External Manufacturing, Supply Chain and Procurement.

Lead technology transfers, process validation, CPV, and post-approval changes while guiding deviations, investigations, and continuous improvements across CMOs/CDMOs.

Qualifications

• BS or equivalent education with extensive experience (14+ years).
• MS or equivalent education with typically 12+ years.
• PhD with typically 6+ years in the relevant discipline.

Responsibilities

• Serve as the primary technical representative to external manufacturing partners for assigned products and processes.
• Maintain detailed understanding of manufacturing processes, critical parameters, quality attributes, process controls, equipment capabilities, and process performance.
• Review manufacturing performance and identify trends, risks, variability, and opportunities for improvement.
• Provide technical leadership for deviations, investigations, CAPAs, and troubleshooting.
• Assess the technical impact of manufacturing changes across equipment, materials, parameters, scale, and facilities.
• Lead or support technology transfers, process scale-up, PPQ, CPV, and site introductions.
• Provide input to change controls, regulatory submissions, validation strategies, and product lifecycle management.
• Partner with Quality to ensure GMP standards in external manufacturing operations.
• Work with Supply Chain to mitigate risks affecting product supply.
• Lead governance discussions with CMOs/CDMOs and escalate issues as needed.
• Develop and monitor process performance metrics and communicate risks and improvements.

Skills

GMP knowledge

External partner influence

Technical leadership

Education

BS or equivalent education

MS or equivalent education

PhD with experience

Job description

AbbVie Inc. seeks a Technical Lead to oversee external manufacturing partners for drug substance and intermediates. You will ensure robust, compliant processes and deliver consistently high-quality product through cross-functional collaboration with Quality, Regulatory, External Manufacturing, Supply Chain and Procurement.

Lead technology transfers, process validation, CPV, and post-approval changes while guiding deviations, investigations, and continuous improvements across CMOs/CDMOs.