Shift Lead - Oral Solid Dosage Manufacturing (OSD)
Novartis
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
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.
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
Benefits
- Health Benefits
- Life Insurance
- Disability Benefits
- 401(k) Matching
- Performance-Based Cash Incentive
- Annual Equity Awards
- Vacation
- Personal Days
- Holidays
- Other Leaves
Company overview
Novartis is a global pharmaceutical company headquartered in Basel, Switzerland, dedicated to reimagining medicine to improve and extend people's lives. As an innovative medicines company, Novartis focuses on developing high-value treatments that address society's greatest disease burdens through technology leadership in research and development. The company operates across five core therapeutic areas: cardiovascular, renal and metabolic diseases; immunology; neuroscience; oncology; and hematology. With a workforce of approximately 75,883 employees worldwide, Novartis reaches nearly 300 million patients across 118 countries. The company leverages advanced technology platforms including targeted protein degradation, cell therapy, gene therapy, radioligand therapy, and xRNA to develop breakthrough treatments. Novartis maintains a strong portfolio of oncology drugs and generics while continuously expanding its pipeline through strategic acquisitions and internal research. The company's commitment extends beyond drug development to ensuring global access to medical innovations through novel access approaches and patient assistance programs.