MS&T Lead, Isotopes

U473 (FCRS = US473) Novartis Innovative Technologies Inc; Indianapolis (IN); On-site; USD 114,000 - 212,000; Full time

Job summary

Novartis AG is seeking an MS&T Lead for Isotopes in Indianapolis to provide scientific and technical leadership, developing site capabilities and supporting robust manufacturing and launches.

You will guide validation, tech transfers, continuous improvement, and inspection readiness, collaborating with global teams to strengthen process robustness and drive manufacturing excellence.

Qualifications

• University degree in science, pharmacy, chemical engineering, pharmaceutical technology, or equivalent experience.
• Minimum 10 years of experience in manufacturing. Additional specialist experience is preferred (e.g., pharmaceutical formulation, process development, manufacturing technology).
• 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.

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, ensuring 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.

Skills

Applied Statistics

Change Controls

Data Analytics

Quality Compliance

Regulatory Compliance

Process Validation

Process Control

Manufacturing Processes

Manufacturing Production

Manufacturing Technologies

Operational Excellence

Technical Leadership

Risk Management

Technology Transfer

Education

University degree in science / pharmacy / chemical engineering / pharmaceutical technology or equivalent experience

Job description

Job Description Summary Location: Indianapolis, Indiana Help build the technical foundation for our new Isotopes site in Indianapolis. As MS&T Lead, Isotopes, you will provide scientific and technical leadership while developing the capabilities needed to support reliable manufacturing. You’ll guide product and technical stewardship, validation, technical transfers, launches, and continuous improvement. Working closely with site and global teams, you’ll help strengthen process robustness, support inspection readiness, and advance manufacturing excellence. #LI-Onsite

Job Description Key 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, ensuring 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.

Essential Requirements

• University degree in science, pharmacy, chemical engineering, pharmaceutical technology, or equivalent experience.
• Minimum 10 years of experience in manufacturing. Additional specialist experience is preferred (e.g., pharmaceutical formulation, process development, manufacturing technology).
• 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.

The salary for this position is expected to range between $98,700 and $183,300 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.

Salary Range $114,100.00 - $211,900.00

Skills Desired

• Applied Statistics
• Change Controls
• Cleaning Validations
• Data Analytics
• Emotional Resilience
• Good Documentation Practices
• Health, Safety, and Environment (HSE) Policy
• Manufacturing Processes
• Manufacturing Production
• Manufacturing Technologies
• Operational Excellence
• Process Control
• Process Validation
• Quality Compliance
• Regulatory Compliance
• Risk Management
• Technical Leadership
• Technology Transfer

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.