Manufacturing Operator II, Oral Solid Dosage (OSD)
Novartis
Summary
Help shape the future of pharmaceutical manufacturing at Novartis. As a Manufacturing Operator II, Oral Solid Dosage (OSD), you'll play a key role in producing high-quality tablet and capsule therapies in a state-of-the-art GMP manufacturing environment. Joining our growing Morrisville team offers the unique opportunity to contribute to a new manufacturing site from the ground up while developing expertise across critical OSD operations.
Job description
Job Description Summary
Help shape the future of pharmaceutical manufacturing at Novartis. As a Manufacturing Operator II, Oral Solid Dosage (OSD), you'll play a key role in producing high-quality tablet and capsule therapies in a state-of-the-art GMP manufacturing environment. Joining our growing Morrisville team offers the unique opportunity to contribute to a new manufacturing site from the ground up while developing expertise across critical OSD operations.
Key Responsibilities
- Execute OSD manufacturing activities according to production schedules in compliance with GMP and safety requirements.
- Operate, monitor, and troubleshoot equipment used in tablet and capsule manufacturing processes.
- Perform manufacturing activities across granulation, compression, coating, and encapsulation operations.
- Complete batch records accurately, thoroughly, and on time in accordance with GMP expectations.
- Conduct equipment setup, cleaning, line clearance, and room preparation activities.
- Perform in-process checks, sampling activities, and routine production monitoring.
- Identify equipment or process issues and escalate deviations to Operations and QA.
- Support FDA inspection readiness through strict adherence to procedures and documentation standards.
- Contribute to continuous improvement initiatives that enhance safety, quality, and manufacturing efficiency.
- Maintain a safe, compliant, and organized manufacturing environment through strong HSE and 5S practices.
Essential Requirements
- Bachelor's degree in Biology, Chemistry, Biotechnology, or a related scientific field with 2+ years of cGMP manufacturing experience, or equivalent relevant experience.
- Hands-on experience in Oral Solid Dosage (OSD) manufacturing, including tablet and capsule production, required.
- Experience operating, monitoring, and troubleshooting manufacturing equipment in an FDA-regulated environment.
- Strong understanding of GMP requirements, batch documentation, and manufacturing procedures.
- Ability to investigate, document, and escalate equipment, process, or quality issues.
- Effective communication and collaboration skills with the ability to work across Operations, QA, and cross-functional teams.
Requirements
- Bachelor's degree in Biology, Chemistry, Biotechnology, or a related scientific field with 2+ years of cGMP manufacturing experience, or equivalent relevant experience.
- Hands-on experience in Oral Solid Dosage (OSD) manufacturing, including tablet and capsule production, required.
- Experience operating, monitoring, and troubleshooting manufacturing equipment in an FDA-regulated environment.
- Strong understanding of GMP requirements, batch documentation, and manufacturing procedures.
- Ability to investigate, document, and escalate equipment, process, or quality issues.
- Effective communication and collaboration skills with the ability to work across Operations, QA, and cross-functional teams.
Benefits
- Health, Life & Disability Benefits
- 401(k) with company match
- Performance-based cash incentive
- Annual equity awards
- Vacation, Personal Days & Holidays
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.