MS&T Lead, Isotopes
About The Position
The MS&T Lead, Isotopes will provide scientific and technical leadership and develop the technical capabilities needed to support reliable manufacturing at Novartis’s new Isotopes site in Indianapolis, Indiana. The role provides product and technical stewardship, validation, technical transfer, product launch, and continuous improvement support. It works closely with site and global teams to strengthen process robustness, support inspection readiness, and advance manufacturing excellence. The position oversees technical stewardship throughout the commercial lifecycle, owns the site Validation Master Plan, and leads technical transfers and commercial scale-up and launches. It also supports the operational start-up of new manufacturing equipment and areas, manages technical changes and complex manufacturing issues, and advances site expertise, knowledge management, and process improvements.
Requirements
- University degree in science, pharmacy, chemical engineering, pharmaceutical technology, or equivalent experience.
- Minimum 10 years of experience in manufacturing.
- Proven experience driving quality and compliance within an organization.
- Strong working knowledge of applied statistics and quality systems.
- Strong working knowledge of regulatory requirements across multiple health authorities.
- Fundamental understanding of standard pharmaceutical analytical testing.
Nice To Haves
- Additional specialist experience, such as pharmaceutical formulation, process development, or manufacturing technology.
Responsibilities
- Provide scientific and technical leadership within Manufacturing Science & Technology and help develop site technical capabilities.
- Ensure robust product and process stewardship and end-to-end technical oversight throughout the commercial lifecycle.
- Own the site Validation Master Plan and ensure manufacturing, packaging, and cleaning processes remain validated.
- Lead technical transfers and enable robust commercial scale-up and launch of new products.
- Drive technical excellence during operational start-up of new manufacturing equipment and areas.
- Oversee technical changes, inspection readiness, regulatory support, and resolution of complex manufacturing issues.
- Build specialist technical expertise, strengthen knowledge management, and advance manufacturing and process improvements across the site.
Benefits
- Performance-based cash incentive.
- Eligibility to be considered for annual equity awards, depending on role level.
- Health benefits.
- Life benefits.
- Disability benefits.
- 401(k) with company contribution and match.
- Vacation, personal days, holidays, and other leaves.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
