Product Steward

NCBiotech; Durham (NC); On-site; USD 126,000 - 234,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Paid time off

Job summary

Novartis in Morrisville, North Carolina, is seeking a Product Steward to act as the technical expert for maintaining deep product and process knowledge throughout the commercial lifecycle. You will leverage data analytics, process monitoring, and scientific expertise to keep products in a state of control, drive improvements, and support robust manufacturing operations.

The role involves leading investigations, validating processes, and partnering with cross-functional teams to deliver

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific field.
• Minimum five years of experience in Oral Solid Dosage pharmaceutical manufacturing.
• Strong understanding of pharmaceutical manufacturing processes, GMPs and regulatory requirements.
• Experience using data trending, statistical analysis and process monitoring to drive decisions.
• Proven ability to investigate process issues, identify root causes and implement corrective actions.
• Demonstrated collaboration across technical, quality, and manufacturing functions.

Responsibilities

• Serve as the product subject matter expert throughout the commercial manufacturing lifecycle.
• Monitor process performance through data trending and statistical analysis.
• Lead technical investigations and drive CAPAs for process-related issues.
• Maintain product-specific quality risk assessments and support control strategies.
• Ensure products remain in validation through process verification activities.
• Partner with cross-functional teams to deliver process improvements and manufacturing excellence projects.
• Support regulatory readiness, product transfers, and technical change implementation.

Skills

Data analytics

Process monitoring

Statistical analysis

Root cause analysis

Cross-functional collaboration

Quality systems

Education

Bachelor’s degree in Pharmacy, Pharmaceutical Technology, Chemistry

Equivalent scientific degree

Master of Science (Desirable)

Job description

Job Description Summary

Location: Morrisville, North Carolina

Are you passionate about turning data into insights that improve product quality and manufacturing performance? Join Novartis as a Product Steward and become the technical expert responsible for maintaining deep product and process knowledge throughout the commercial lifecycle. In this highly visible role, you will use data analytics, process monitoring, and scientific expertise to ensure products remain in a state of control, drive continuous improvement initiatives, and support robust, reliable manufacturing operations. Working across multiple functions, you will play a key role in product stewardship, process validation, technical investigations, and operational excellence while helping deliver high-quality medicines to patients.

Job Description

Key Responsibilities

• Serve as the product subject matter expert throughout the commercial manufacturing lifecycle.
• Monitor process performance through data trending, statistical analysis, and ongoing product oversight.
• Lead technical investigations and drive effective corrective and preventive actions for process-related issues.
• Maintain product-specific quality risk assessments and support robust process control strategies.
• Ensure products remain in a continued state of validation through ongoing process verification activities.
• Partner with cross-functional teams to deliver process improvements, optimization initiatives, and manufacturing excellence projects.
• Support regulatory readiness, product transfers, and technical change implementation for assigned products.

Essential Requirements

• Bachelor’s degree in Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent scientific degree.
• Minimum five years of experience in Oral Solid Dosage pharmaceutical manufacturing environments.
• Strong understanding of pharmaceutical manufacturing processes, regulatory requirements, and GMPs.
• Experience using data trending, statistical analysis, and process monitoring to drive decision-making.
• Proven ability to investigate process issues, identify root causes, and implement effective corrective actions.
• Demonstrated experience working collaboratively across technical, quality, and manufacturing functions.

Desirable Requirements

• Master of Science degree in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field.
• Experience supporting product transfers, process optimization initiatives, and manufacturing excellence programs.

The salary for this position is expected to range between $126,000 and $234,000 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.

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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.

Salary Range

$126,000.00 - $234,000.00

Skills Desired

Applied Statistics, Change Controls, Data Analytics and Digital (Inactive), GDP Knowledge (Inactive), Good Manufacturing Practices (GMP), HSE Knowledge (Inactive), Manufacturing Processes, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process and Cleaning Validation (Inactive), Process Control, Quality Compliance, Regulatory Compliance, Resilience and Risk Management (Inactive), Technical Leadership, Technology Transfer