Novartis
Manufacturing Unit Lead-Drug Substance
Durham · Director
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About the role
- Serve as the process owner and end-user representative for Drug Substance (DS) manufacturing, process equipment, and systems throughout the project lifecycle.
- Provide technical leadership for manufacturing processes, equipment, validation, and operational readiness activities.
- This is an Associate Director level role.
Responsibilities
- Lead Drug Substance manufacturing operations from facility start-up through commercial production. Serve as the process owner and end-user representative for Drug Substance (DS) manufacturing, process equipment, and systems throughout the project lifecycle.
- Build, lead, coach, and develop a high-performing manufacturing team while maintaining training compliance.
- Drive inspection readiness and support successful regulatory inspections, audits, and compliance activities.
- Lead deviation investigations, root cause analysis, and implementation of effective Corrective and Preventive Actions.
- Explore and leverage data and technology to support the site's digital transformation journey.
- Minimum 5 years of people leadership experience managing manufacturing operations and developing high-performing teams.
- Proven ability to drive operational excellence, continuous improvement, and cross-functional collaboration in a regulated environment.
- Lead Drug Substance manufacturing operations from facility start-up through commercial production.
- As Manufacturing Unit Head, you will play a pivotal role in building and leading a high-performing team while shaping the future of manufacturing operations at our new Morrisville site.
- From facility start-up and operational readiness through commercial operations, you will drive manufacturing excellence, foster a culture of safety and quality, and deliver reliable supply for patients.
Requirements
- Bachelor's degree in Engineering, Chemistry, Biology, Pharmacy, or related scientific discipline.
- Experience with Active Pharmaceutical Ingredients (API), freeze drying (lyophilization), manufacturing skids, and oligonucleotide manufacturing.
- Minimum 10 years of pharmaceutical or life sciences manufacturing experience in GMP environment.
- Strong knowledge of Drug Substance manufacturing processes, validation, qualification, and commercial operations.
Compensation
- $138,600.00 - $257,400.00
Benefits
- This is a unique opportunity to make a lasting impact by combining technical expertise, people leadership, and strategic vision to establish world-class manufacturing capabilities from the ground up.
This listing is sourced directly from Novartis's careers page and normalized into a canonical job model.