Site MS&T Head SMO - Drug Substance

U473 (FCRS = US473) Novartis Innovative Technologies Inc; Morrisville (NC); On-site; USD 139,000 - 257,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous time off package

Job summary

Novartis Innovative Technologies Inc. in Morrisville, NC seeks an Associate Director-level Site MS&T Head for Drug Substance to lead strategy, manufacturing science, and site-wide product stewardship.

You will build and guide a high-performing DS MS&T organization, drive process robustness, oversee tech transfers, validation, compliance, and enable successful launches while developing talent. The role partners with global teams to accelerate breakthrough therapies with quality, reliability, and

Qualifications

• Bachelor’s Degree required; Master’s degree preferred in Science, Pharmacy, Chemical Engineering or related field.
• Minimum 10 years of experience in manufacturing; additional specialist experience preferred (formulation, process development, manufacturing technology).
• Proven experience driving quality and compliance across health authorities.
• Strong knowledge of applied statistics, quality systems, and regulatory requirements.
• Demonstrated leadership building and leading high-performing technical teams.

Responsibilities

• Lead the 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 product lifecycle.
• Drive process robustness, continuous improvement, and manufacturing excellence across products and technologies.
• Oversee validation programs, technical changes, and compliance activities to maintain inspection readiness.
• Lead technology transfers, product launches, and scale-up activities; partner with global teams to resolve technical challenges.

Skills

Applied Statistics

Leadership

Manufacturing Production

Manufacturing Technologies

Operational Excellence

Process Control

Quality Compliance

Regulatory Compliance

Technical Leadership

Technology Transfer

Education

Bachelor’s degree

Master’s degree in Science/Engineering/Pharmacy

Job description

Job Description Summary

Location: 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.

Key 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.

Essential Requirements

Bachelor’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 Requirements

Diverse pharmaceutical experience needed. Specifically, Small Molecule experience - API/Drug Substance/Oligonucleotide is highly preferred.

Salary Range

• The salary for this position is expected to range between $138,600 and $257,400 per year.
• Salary Range $138,600.00 - $257,400.00.

Compensation and Benefits

• 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.

Skills Desired

Applied Statistics, Leadership, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process Control, Quality Compliance, Regulatory Compliance, Technical Leadership, Technology Transfer.

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 and reasonable accommodations

The 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.

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