Principal Technical Lead, External Manufacturing - Drug Substance
AbbVie
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 25 days ago
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