Production Head, Isotope Manufacturing (Associate Director)

Band

Level 5

Job Description Summary

Location: Indianapolis Indiana USA


Imagine leading the future of radioligand therapy manufacturing and helping deliver life-changing treatments to patients around the world. As Production Head Isotope Manufacturing you will play a pivotal leadership role in establishing and advancing a state-of-the-art isotope production operation in Indianapolis. This is a unique opportunity to build high-performing teams shape manufacturing excellence drive operational performance and foster a culture of safety quality compliance and innovation. Working at the intersection of cutting-edge science and advanced manufacturing you will help ensure the reliable supply of critical therapies while influencing the future growth of Novartis radioligand therapy network.


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Job Description

Key Responsibilities

Lead the Production and Operations Support team to achieve site objectives for Safety Quality Supply Compliance Cost and People.

Establish and maintain manufacturing operations in full cGMP EHS radiation safety and regulatory compliance.

Build develop and coach high-performing teams through training talent development and succession planning.

Drive continuous improvement of manufacturing processes procedures staffing models and training systems.

Own review and approve production documentation including Standard Operating Procedures master batch records executed production records logbooks work orders technical assessments and white papers.

Lead investigations root cause analysis and corrective actions for quality events and manufacturing deviations.

Prepare for and participate in internal audits and Health Authority inspections; ensure personnel qualification and complete accurate and contemporaneous documentation of manufacturing activities.

Partner cross-functionally to support validation technology transfers product launches and operational excellence initiatives.

Manage production performance budgets and operational priorities to ensure reliable patient supply.

Essential Requirements

Bachelor of Science degree in engineering chemistry pharmacy or related field or relevant equivalent experience.

Five or more years of experience in operational roles with direct experience in pharmaceutical manufacturing; low bioburden manufacturing experience preferred.

Three or more years of leadership experience.

Experience supporting regulatory inspections by agencies such as the Food and Drug Administration or European Medicines Agency.

Environment Health and Safety and GxP / QA experience building an injury and error-free culture with knowledge of multiple compliance areas (corporate governance financial quality environment safety).

Demonstrated ability to lead operational excellence drive continuous improvement and build high-performing teams.

Desirable Requirements

Training in radiochemistry or radiopharmacy.

Radiation safety education.

The salary for this position is expected to range between $138600 and $257400 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 -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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

To learn more about the culture rewards and benefits we offer our people click here.

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

$138600.00 - $257400.00

Skills Desired

Data Analytics