Head MS&T RLT (Remote)

Band

Level 7

 

Job Description Summary

At Novartis, we are pioneering the future of cancer treatment through Radioligand Therapy (RLT) - a powerful fusion of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we are seeking passionate, purpose-driven individuals to join our mission of delivering life-changing therapies to patients around the world.

The Head MS&T RLT leads the global RLT MS&T organization, which is responsible to maintain and improve the scientific oversight of the manufacturing processes and technical changes, the relevant body of technical knowledge and capabilities, and to ensure product stewardship in all phases of product lifecycle, end to end throughout the value chain of manufacturing.

You will ensure products are validated and remain in constant state of validation throughout the manufacturing life of the product (including Continued Process Verification CPV and Validation Master Plan VMP tracking). You will support the optimization of Novartis manufacturing processes, enabling full-scale manufacturing through integrated technology strategy and technical support which includes triggering post launch development when needed. You will also ensure best practice is applied in handling of discrepancy and investigation resolution, process validation activities, training on new process technologies and on significant changes to manufacturing procedures.

This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require at least 25% travel.

 

Job Description

Key responsibilities:

• Establish and maintain global and local (manufacturing site and third parties) MS&T organizational capability and governance processes to ensure products and technologies are within validation and current technology standards.
• Develop and implement a global and site-based product/process stewardship approach, at all stages of their commercial lifecycle.
• Ensure oversight, robustness and capability of manufacturing and packaging processes
• Oversee and coordinate product validation activities for new and routinely manufactured commercial products and ensure that products are properly validated according to current GMP and internal Novartis standards.
• Support excellence in manufacturing through standard setting and technical capability development and deployment.
• Provide strong technical leadership within Novartis to ensure product and related packaging operations are maintained in compliance with current GMP and regulatory requirements
• Work with the other MS&T Heads, teams and networks to drive reapplication of standard work processes and best practices, specifically in validation, training, process changes and handling of discrepancy and investigation resolution.
• Ensure members of the MS&T organization are properly trained, instill a sense of community and network, and drive a clear understanding of Novartis quality culture
• Manage the MS&T talent pipeline within the Region (or Business Unit, or Franchise) through appropriate career paths, succession planning, training program.
• Input to: Site selection, mid-term capacity planning, equipment purchasing / replacement, manufacturing / footprint strategy, make or buy decision

Essential Requirements:

• BSc degree in chemical engineering, chemistry, pharmacy, or related field.
• Minimum 10 years’ experience in the pharmaceutical industry including relevant experience with sterile manufacturing operations and prior Novartis RLT experience, and a minimum of 5 years of leadership experience.
• Thorough knowledge and understanding of the scientific principles and concepts in chemical or biotechnology & pharmaceutical sciences
• Good interpersonal skills coupled with demonstrated networking capacities allowing to effectively work in a matrix organization and a multi-disciplinary team environment.  
• Good understanding of cGMPs, industry and regulatory standards and guidelines, strong ethical foundation and a sound compliance understanding. 

Desirable Requirements:

• Global experience
• Education/Training in radiochemistry or radiopharmaceuticals

The pay range for this position at commencement of employment is expected to be between $225,400 and $418,600 per year; however, while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determination