Principal Technical Lead, External Manufacturing - Drug Substance
AbbVie · North Chicago, IL
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Role summary
Principal Technical Lead role overseeing external manufacturing partners for drug substance and intermediate manufacturing. Serves as primary technical interface with contract manufacturers, ensuring processes remain robust, compliant, and meet quality standards while collaborating across Quality, Regulatory, and Supply Chain functions.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on SmartRecruiters, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-03 (originally posted 2026-10-03). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- BS degree with 14+ years experience, or MS with 12+ years, or PhD with 6+ years in relevant discipline
- Demonstrated experience with GMP drug-substance manufacturing and process characterization
- Experience with validation, deviations, investigations, and technology transfer
- Experience managing CMO/CDMO relationships and change control processes
- Ability to make technical decisions and influence external partners without direct authority
What you'll be doing
- Serve as primary technical representative to external manufacturing partners for assigned products
- Maintain detailed understanding of manufacturing processes, critical parameters, and equipment capabilities
- Review manufacturing performance, identify trends, risks, and improvement opportunities
- Lead technical response to deviations, investigations, root-cause analyses, and CAPAs
- Support technology transfers, process scale-ups, validations, and regulatory submissions
Privacy & handoff
This role links to AbbVie's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.