Hiring: Manufacturing Unit Lead-Drug Substance Company: Novartis Location: Durham, NC Job Posted Time: 2026-09-10 10:21:06 About the job Experience: •10 years of pharmaceutical or life sciences manufacturing experience in GMP environment. •5 years of people leadership experience managing manufacturing operations and developing high-performing teams. •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. Required Skills: •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. Qualifications: •Bachelor’s degree in Engineering, Chemistry, Biology, Pharmacy, or related scientific discipline. •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. •Lean Management, Operational Excellence certification, or comparable qualifications. •To learn more about the culture, rewards and benefits we offer our people click here. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!