Site MS&T Head, SMO
Listed on 2026-02-16
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Engineering
Quality Engineering, Process Engineer
Overview
The Site, Manufacturing, Science & Technology Head - Small Molecule is an Associate Director level role.
Location:
Morrisville, NC
The Role
You will lead the Manufacturing Science and Technology (MS&T) organization, ensuring our products remain in a state of control through deep product knowledge, process understanding, and the application of technology. Your focus will be on driving continuous improvement while reducing process variability and waste. You will drive end‑to‑end product and process stewardship across the lifecycle, strengthening validation activities, launches, and technical transfers, and ensuring inspection-readiness through standardization, sustainability, innovation, and technology—ultimately enabling patient safety and reliable supply.
By partnering across functions and the global MS&T network, you will accelerate the adoption of best practices, advance Quality by Design, Design of Experiments, and Process Analytical Technology, and build the capabilities needed to shape the future of operations.
If you’re energized by leading experts, influencing strategy, and making a direct impact on how patients receive high‑quality therapies, this role offers a powerful platform.
Key Responsibilities- Define MS&T vision, technical standards, and strategic priorities that strengthen site performance and scientific capability.
- Act as primary liaison with site leadership and global platform heads to align objectives and resolve technical issues.
- Build department technical expertise by overseeing career paths, succession plans, training programs, and cross‑functional knowledge management.
- Ensure inspection readiness and drive rapid reapplication of global best practices, standard processes, and compliance improvements.
- Lead end‑to‑end product and process stewardship to maintain robust, well‑controlled manufacturing throughout the lifecycle.
- Oversee technical change control and serve as site interface for regulatory interactions and submission content.
- Own the Validation Master Plan and ensure execution, monitoring, and continuous verification of validated processes.
- Direct technical transfers, launches, and scale‑ups, ensuring strong project leadership and seamless execution.
- Advance manufacturing excellence by applying Quality by Design, Design of Experiments, and Process Analytical Technology.
- Guide Technology Life Cycle Management, new technology adoption, and ensure technical inputs shape capital project decisions.
- Bachelor’s Degree Required. Master’s degree in Science, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent scientific discipline preferred.
- Minimum 10 years of work experience within the pharmaceutical industry. Extensive experience in manufacturing operations, including product, process, or technology oversight.
- Demonstrated ability to drive quality, compliance, and continuous improvement in a regulated environment.
- Strong understanding of applied statistics, quality systems, and regulatory requirements across multiple health authorities.
- Proven capability in process development, technical problem‑solving, and lifecycle stewardship of commercial products.
- Working knowledge of pharmaceutical analytical testing and its application to process and product understanding.
- Experience leading technical teams, developing talent, and building organizational capabilities.
- Strong ability to collaborate across functions and influence decision‑making at multiple organizational levels.
- Diverse pharmaceutical experience needed. Specifically, Small Molecule DS (API/Drug Substance/Oligonucleotide) / Small Molecule DP/FP (Drug Product/Finished Product) is highly preferred.
The salary for this position is expected to range between $138,600 and $257,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending…
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