## [Manufacturing Unit Lead-Drug Substance](/req-10083243-manufacturing-unit-lead-drug-substance "Manufacturing Unit Lead-Drug Substance") Job ID REQ-10083243 Jul 22, 2026 LOC_US ### About the Role ## 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. To learn more about the culture, rewards and benefits we offer our people click [here.](https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf) \#LI-Onsite ### Role Requirements **Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? [https://www.novartis.com/about/strategy/people-and-culture](https://www.novartis.com/about/strategy/people-and-culture "https://www.novartis.com/about/strategy/people-and-culture") **Benefits and Rewards:** Learn about all the ways we’ll help you thrive personally and professionally. [Read our handbook (PDF 30 MB)](https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf) Division DIV_TO Business Unit Production / Manufacturing Location LOC_US Site Morrisville (North Carolina) Company / Legal Entity U473 (FCRS = US473) Novartis Innovative Technologies Inc Functional Area FCT_TO Job Type Full time Employment Type Regular Shift Work No [Apply to Job](https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Durham/Manufacturing-Unit-Lead-Drug-Substance_REQ-10083243-1 "Apply to Job") ![careers default image](https://prod1.jobapi.novartis.com.cn/themes/custom/cosmos/patterns/images/careers-default-image.webp "careers default image") Job ID REQ-10083243 ### Manufacturing Unit Lead-Drug Substance [Apply to Job](https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Durham/Manufacturing-Unit-Lead-Drug-Substance_REQ-10083243-1 "Apply to Job")