MS&T Lead, Isotopes
About The Position
The MS&T Lead, Isotopes will provide scientific and technical leadership while developing the capabilities needed to support reliable manufacturing at the new Isotopes site in Indianapolis, Indiana. The role guides product and technical stewardship, validation, technical transfers, product launches, and continuous improvement, working with site and global teams to strengthen process robustness, support inspection readiness, and advance manufacturing excellence. The position provides end-to-end technical oversight throughout the commercial product lifecycle, owns the site Validation Master Plan, and leads technical transfers and commercial scale-up. It also supports operational start-up of new manufacturing equipment and areas, oversees technical changes and regulatory support, resolves complex manufacturing issues, develops specialist expertise and knowledge management, and advances manufacturing and process improvements across the site.
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.
- Depending on role level, eligibility to be considered for annual equity awards.
- Health, life, and disability benefits.
- 401(k) with company contribution and match.
- Vacation, personal days, holidays, and other leaves.
- A variety of other benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
