drjobs Head MS&T RLT (Remote)

Head MS&T RLT (Remote)

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1 Vacancy
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Job Location drjobs

Indianapolis, IN - USA

Monthly Salary drjobs

$ 225400 - 418600

Vacancy

1 Vacancy

Job Description

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 $225400 and $418600 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 determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a sign-on bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.



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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.



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 in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$225400.00 - $418600.00


Skills Desired

Change Management Manufacturing Process Science Manufacturing Technologies Npd (New Product Development) Process Simulation Quality Compliance R&D (Research And Development) Technical Leadership Waterfall Model

Employment Type

Full-Time

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