Manufacturing Unit Lead-Drug Substance

Novartis Group Companies; Durham (NC); On-site; USD 138,600 - 257,400; Full time

Job summary

Novartis Group Companies is seeking an Associate Director to lead Drug Substance manufacturing operations from facility startup through commercial production at the Morrisville site in North Carolina. The role serves as process owner for DS manufacturing, equipment, and systems across the project lifecycle.

The candidate will provide technical leadership, ensure cGMP compliance, and build a high-performing team while driving readiness for inspections and regulatory audits.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, Pharmacy, or related discipline.
• 10+ years of pharmaceutical or life sciences GMP manufacturing experience.
• 5+ years of people leadership in manufacturing operations.
• Experience leading quality, compliance, inspections, and regulatory audits.
• Strong knowledge of Drug Substance manufacturing processes, validation, qualification, and operations.
• Proven ability to drive operational excellence and cross-functional collaboration in a regulated environment.

Responsibilities

• Lead Drug Substance manufacturing operations from facility start-up through commercial production.
• Provide technical leadership for manufacturing processes, equipment, validation, and readiness activities.
• Ensure safe, compliant manufacturing operations aligned with cGMP requirements.
• Build, lead, coach, and develop a high-performing manufacturing team with training compliance.
• Drive inspection readiness and support regulatory inspections, audits, and compliance activities.
• Lead deviation investigations, root cause analyses, and CAPA implementation.
• Champion operational excellence initiatives to enhance productivity and manufacturing performance.
• Explore data and technology to support the site's digital transformation journey.

Skills

Data Analytics

Education

Bachelor's degree in Engineering, Chemistry, Biology, Pharmacy, or related scientific discipline

Job description

Job Description Summary

Location: Morrisville, NC

This is an Associate Director level role.

Job Description

Key Responsibilities

• Lead Drug Substance manufacturing operations from facility start-up through commercial production. Serve as the process owner and end-user representative for Drug Substance (DS) manufacturing, process equipment, and systems throughout the project lifecycle.
• Provide technical leadership for manufacturing processes, equipment, validation, and operational readiness activities.
• Ensure safe, compliant, and reliable manufacturing operations aligned with cGMP requirements.
• Build, lead, coach, and develop a high-performing manufacturing team while maintaining training compliance.
• Drive inspection readiness and support successful regulatory inspections, audits, and compliance activities.
• Lead deviation investigations, root cause analysis, and implementation of effective Corrective and Preventive Actions.
• Champion operational excellence initiatives to enhance productivity, process robustness, and manufacturing performance.
• Explore and leverage data and technology to support the site's digital transformation journey.

Essential Requirements

• Bachelor's degree in Engineering, Chemistry, Biology, Pharmacy, or related scientific discipline.
• Minimum 10 years of pharmaceutical or life sciences manufacturing experience in GMP environment.
• Minimum 5 years of people leadership experience managing manufacturing operations and developing high-performing teams.
• Demonstrated experience leading quality, compliance, inspection readiness, and regulatory audit activities.
• Strong knowledge of Drug Substance manufacturing processes, validation, qualification, and commercial operations.
• Proven ability to drive operational excellence, continuous improvement, and cross-functional collaboration in a regulated environment.

Desirable Requirements

• Experience with Active Pharmaceutical Ingredients (API), freeze drying (lyophilization), manufacturing skids, and oligonucleotide manufacturing.
• Lean Management, Operational Excellence certification, or comparable qualifications.

The salary for this position is expected to range between $138,600 and $257,400 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

$138,600.00 - $257,400.00

Skills Desired

Data Analytics