Site MS&T Head SMO - Drug Substance

Novartis Farmacéutica; Morrisville (NC); On-site; USD 139,000 - 257,000; Full time

Job summary

Novartis is seeking the Site MS&T DS Head for Drug Substance (Associate Director) in Morrisville, NC to lead the scientific and technical strategy across the manufacturing site, driving lifecycle excellence and product stewardship.

You will lead the MS&T DS organization, guide process robustness, validation, tech transfers, and inspections readiness, and partner with global teams to enable launches and continuous improvement.

Qualifications

• Bachelor’s Degree required.
• Master’s degree in Science, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent preferred.
• Minimum 10 years of experience in manufacturing.
• Proven experience driving quality and compliance in an organization.
• Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
• Fundamental understanding of standard pharmaceutical analytical testing.
• Demonstrated leadership experience building, developing, and leading high-performing technical and scientific teams.

Responsibilities

• Lead the site MS&T DS organization, setting vision, priorities, and technical strategy aligned with site objectives.
• Ensure end-to-end product stewardship and technical oversight throughout the commercial product lifecycle.
• Drive process robustness, continuous improvement, and manufacturing excellence across products, processes, and technologies.
• Oversee technical changes, validation programs, and compliance activities to maintain inspection readiness.
• Lead technology transfers, product launches, and scale-up activities to deliver successful implementation outcomes.
• Partner with site and global teams to resolve technical challenges and strengthen process capability.
• Develop technical talent, succession plans, and knowledge-sharing programs to build organizational capability.

Skills

Leadership

Statistics

Quality systems

Regulatory knowledge

Pharmaceutical manufacturing

Education

Bachelor’s Degree in Science, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent

Master’s degree preferred

Job description

SummaryLocation: Morrisville, NC**The Site, Manufacturing, Science & Technology Head - Small Molecule Drug Substance is an Associate Director level role.**Imagine leading the scientific and technical strategy behind a cutting-edge manufacturing site that delivers life-changing medicines to patients around the world. As the Site MS&T Head for Drug Substance (DS), you will play a critical leadership role in shaping manufacturing excellence, driving innovation, and ensuring robust product stewardship across the full product lifecycle. You will lead a highly skilled Manufacturing Science & Technology DS organization, partnering across site functions and global teams to optimize processes, enable successful product launches and transfers, strengthen validation and compliance programs, and build the technical capabilities that support the future growth of the Morrisville site. In this highly visible position, you will influence site strategy, develop top talent, and help bring breakthrough therapies to patients with quality, reliability, and speed.About the RoleKey ResponsibilitiesLead the site MS&T DS organization, setting vision, priorities, and technical strategy aligned with site objectives.Ensure end-to-end product stewardship and technical oversight throughout the commercial product lifecycle.Drive process robustness, continuous improvement, and manufacturing excellence across products, processes, and technologies.Oversee technical changes, validation programs, and compliance activities to maintain inspection readiness.Lead technology transfers, product launches, and scale-up activities to deliver successful implementation outcomes.Partner with site and global teams to resolve technical challenges and strengthen process capability.Develop technical talent, succession plans, and knowledge-sharing programs to build organizational capability.Essential RequirementsBachelor’s Degree Required. Master’s degree in Science, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent scientific discipline preferred.Minimum 10 years of experience in manufacturing. Additional specialist experience is preferred (e.g., pharmaceutical formulation, process development, manufacturing technology).Proven experience driving quality and compliance in an organization.Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.Fundamental understanding of standard pharmaceutical analytical testing. .Demonstrated leadership experience building, developing, and leading high-performing technical and scientific teams.Desirable RequirementsDiverse pharmaceutical experience needed. Specifically, Small Molecule experience - API/Drug Substance/Oligonucleotide 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 on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.To learn more about the culture, rewards and benefits we offer our people click here.#LI-OnsiteWhy Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.Read our handbook (PDF 30 MB)EEO Statement:The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.Accessibility & Reasonable AccommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.DivisionOperationsBusiness UnitGeneral ManagementLocationUSAStateNorth CarolinaSiteMorrisville (North Carolina)Company / Legal EntityU473 (FCRS = US473) Novartis Innovative Technologies IncFunctional AreaTechnical OperationsJob TypeFull timeEmployment TypeRegularShift WorkNo