Principal Technical Lead, External Manufacturing - Drug Substance
Core
Provide technical oversight and stewardship for external manufacturing partners (CMOs/CDMOs) to ensure robust, compliant, and reproducible drug substance and intermediate manufacturing processes.
Role type
Principal Technical Lead, External Manufacturing
Builds
Drug substance and intermediate products for AbbVie's therapeutic areas (immunology, oncology, neuroscience)
Domain
Biopharmaceutical manufacturing (Drug Substance)
Required skills
GMP drug-substance manufacturing, process characterization, validation, deviations/investigations, technology transfer, change control, CMO/CDMO management, root-cause analysis, process scale-up, regulatory submissions, lifecycle management
Preferred skills
Process monitoring, manufacturing efficiency improvement, yield optimization, cross-functional stakeholder influence (via careerplan.io/jobs/3743990015872646-principal-technical-lead-external-manufacturing-drug-substance-at-abbvie)
Technologies
None explicitly listed
Responsibilities
Serve as primary technical interface with external manufacturing partners; review manufacturing performance and identify process trends/risks; lead technical governance discussions with CMOs/CDMOs; support technology transfers, process scale-up, and validation; partner with Quality to ensure GMP standards; support regulatory inspections and submissions.
Seniority
Principal, strategy & mentorship