Senior Clinical Manufacturing Lead — GMP & Process

AbbVie; North Chicago (IL); On-site; USD 97,000 - 184,000; Full time

Job summary

AbbVie in United States (North Chicago) seeks a senior leader to oversee production teams for solid dosage form clinical supplies, ensuring GMP-compliant processes and timely manufacturing using state-of-the-art technologies.

The role requires guiding formulation development, providing technical manufacturing guidance, and coordinating with QA, CMC, and other groups to meet project goals while maintaining high quality and compliance.

Qualifications

• B.S. in Chemistry, Biology or related scientific area or equivalent with relevant experience.
• 10+ years experience in operations, R&D and/or related area.
• Experience in a cGMP environment is highly desired.

Responsibilities

• Leads manufacturing activities, including preparation and close out of batch records; ensures the batch record documentation is executed with minimal errors; starts and completes manufacturing activities on time, according to the established schedule.
• May supervise the pilot plant technicians including daily scheduling of activities, managing personnel development, holding technicians accountable against performance expectations, and writing and delivering performance reviews.
• Collaborates with formulators on formulation development and research activities occurring in the pilot plant.
• Provides detailed knowledge of pilot plant equipment and processing capabilities; provides technical guidance to manufacturing personnel; participates in optimization initiatives.
• Understands and follows cGMP requirements, established policies; writes and follows procedures; follows safety requirements.
• Works with the CMC team to assure project commitments; provides draft batch records for review; ensures material availability and inventory transactions.
• Records, tabulates and reports results; communicates significant issues to management; participates in group meetings.
• Directs activities of manufacturing technicians in a matrix environment.

Education

B.S. in Chemistry, Biology or related scientific area or equivalent

Job description

AbbVie in United States (North Chicago) seeks a senior leader to oversee production teams for solid dosage form clinical supplies, ensuring GMP-compliant processes and timely manufacturing using state-of-the-art technologies.

The role requires guiding formulation development, providing technical manufacturing guidance, and coordinating with QA, CMC, and other groups to meet project goals while maintaining high quality and compliance.