Manufacturing Unit Lead - Drug Substance

About the role

Novartis is looking for an Associate Director level Manufacturing Unit Lead for Drug Substance at its new Morrisville site in North Carolina. You will lead the launch and long-term success of a state-of-the-art Drug Substance manufacturing organization, building and leading a high-performing team from facility start-up and operational readiness through commercial operations. The role combines technical expertise, people leadership and strategic vision.

Key responsibilities

• Lead Drug Substance manufacturing operations from facility start-up through commercial production, acting as process owner and end-user representative for DS manufacturing, process equipment and systems.
• Provide technical leadership for manufacturing processes, equipment, validation and operational readiness.
• Ensure safe, compliant and reliable manufacturing aligned with cGMP requirements.
• Build, lead, coach and develop a manufacturing team while maintaining training compliance.
• Drive inspection readiness and support regulatory inspections, audits and compliance activities.
• Lead deviation investigations, root cause analysis and corrective and preventive actions.
• Champion operational excellence initiatives and use data and technology to support the site's digital transformation.

Required profile

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

Desirable requirements

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

What we offer

• Expected salary range of $138,600 to $257,400 per year, with a performance-based cash incentive and possible annual equity awards.
• Health, life and disability benefits, 401(k) with company contribution and match.
• Vacation, personal days, holidays and other leaves.