Shift Lead - Oral Solid Dosage Manufacturing (OSD)

U473 (FCRS = US473) Novartis Innovative Technologies Inc; Morrisville (NC); On-site; USD 85,000 - 159,000; Full time

Benefits offered by this job

Health benefits

401(k) matching

Paid time off

Life insurance

Disability benefits

Job summary

Novartis in Morrisville, NC is seeking a Shift Lead to head day-shift OSD manufacturing operations at our new site. You will build and coach a high-performing team, drive safety, quality, and operational excellence, and help establish this startup-like facility as a center of manufacturing excellence.

The role requires a Bachelor's in a scientific/technical field with GMP experience or equivalent years, deep knowledge of FDA requirements, and a proven track record leading regulated manufacturing

Qualifications

• Bachelor's degree in a scientific/technical field with 5+ years GMP manufacturing experience.
• Alternatively, 7+ years GMP manufacturing experience in lieu of a degree.
• Experience in small molecule pharmaceutical manufacturing, OS manufacturing preferred.

Responsibilities

• Lead daily OSD manufacturing operations to maintain safety, quality, and production goals.
• Coach and develop a team of manufacturing associates across multiple areas.
• Ensure FDA GMP compliance and accurate batch documentation.
• Lead investigations, CAPAs, and drive continuous improvement.
• Coordinate schedules, staffing, and resources to support on-time batch execution.
• Foster a culture of safety and operational excellence.

Skills

People leadership

GMP compliance

Batch records

FDA regulations

Root cause analysis

Quality systems

Education

Bachelor's degree in a scientific or technical discipline

Job description

Job Description Summary Ready to lead a team that's building the future of manufacturing at Novartis? As a Shift Lead, you'll oversee OSD production operations, develop and coach a high-performing team, and drive safety, quality, and operational excellence in our new Morrisville facility. This is a unique opportunity to make your mark in a startup environment while helping deliver medicines to patients around the world.

Job Description Location: This position will be located in Morrisville, NC and will be an onsite role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

#LI-Onsite

Shift: Day shift (Monday-Friday). Hours TBD as this is a new site and operating schedules are still being finalized

Key Responsibilities

• Lead daily OSD manufacturing operations to achieve safety, quality, and production objectives.
• Supervise, coach, and develop a team of manufacturing associates across multiple production areas.
• Drive GMP compliance and ensure activities meet FDA and quality requirements.
• Lead Tier 1 meetings and communicate operational priorities, performance, and escalations.
• Coordinate production schedules, staffing, and resources to support on-time batch execution.
• Review manufacturing documentation and ensure accurate completion of batch records and related documentation.
• Lead deviation investigations, implement CAPAs, and drive continuous improvement initiatives.
• Foster a culture of safety, accountability, teamwork, and operational excellence across the shift.

Essential Requirements

• Bachelor's degree in a scientific or technical discipline with 5+ years of GMP manufacturing experience; or 7+ years of GMP manufacturing experience in lieu of a degree.
• Hands-on experience in small molecule pharmaceutical manufacturing, preferably within Oral Solid Dosage (OSD) operations.
• Experience supporting one or more OSD manufacturing processes, including granulation, compression, coating, or encapsulation.
• Demonstrated people leadership experience with the ability to coach, develop, and lead manufacturing teams in a regulated environment.
• Strong knowledge of FDA regulations, GMP requirements, manufacturing documentation, and quality systems.
• Experience leading investigations, resolving deviations, implementing CAPAs, and driving continuous improvement initiatives.

Novartis Compensation and Benefit Summary

Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $85,400 and 158,600.00 annually 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.

Salary Range $85,400.00 - $158,600.00

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, 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.

Skills Desired Data Analytics

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.