Associate Director, Drug Substance Manufacturing

Novartis; Rhode Island; On-site; USD 139,000 - 257,000; Full time

Job summary

Novartis is seeking an Associate Director-level leader for Drug Substance manufacturing in Morrisville, NC. This role oversees DS manufacturing operations from facility start-up through commercial production, serving as the process owner for DS processes, equipment, and systems.

You will provide technical leadership for manufacturing processes, validation, and operational readiness, while building and mentoring a high-performing team.

Qualifications

• 10+ years of pharmaceutical or life sciences GMP manufacturing experience.
• 5+ years of people leadership in manufacturing operations.
• Experience leading quality, compliance, inspection readiness, and regulatory audits.
• Strong knowledge of Drug Substance manufacturing processes, validation, qualification, and commercial operations.
• Proven ability to drive operational excellence and cross-functional collaboration in a regulated environment.
• Desirable: API experience, lyophilization, manufacturing skids, and oligonucleotide manufacturing.
• Lean Management or Operational Excellence qualifications preferred.

Responsibilities

• Lead Drug Substance manufacturing operations from facility start-up through commercial production; act as process owner for DS manufacturing, equipment, and systems.
• 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 regulatory inspections, audits, and compliance activities.
• Lead deviation investigations, root cause analysis, and implementation of effective CAPA.
• 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.

Education

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

Job description

Novartis is seeking an Associate Director-level leader for Drug Substance manufacturing in Morrisville, NC. This role oversees DS manufacturing operations from facility start-up through commercial production, serving as the process owner for DS processes, equipment, and systems.

You will provide technical leadership for manufacturing processes, validation, and operational readiness, while building and mentoring a high-performing team.