Associate Director, PET Drug Manufacturing Operations

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Associate Director, PET Drug Manufacturing Operations

Jubilant DraxImage, Inc. dba Jubilant Radiopharma is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here.

JOB DESCRIPTION

Associate Director, PET Drug Manufacturing Operations

Location: Remote (United States) with travel up to 50%

About Jubilant Radiopharmacies

At Jubilant Radiopharmacies, we help deliver life-changing diagnostic imaging that supports earlier detection and better patient outcomes. Our team manufactures and distributes PET radiopharmaceuticals used every day in hospitals and clinics across the country. We are committed to safety, quality, and innovation-and to creating an inclusive environment where talented people can grow and make an impact.

Why This Role - Why Now at Jubilant Radiopharmacies

Jubilant Radiopharmacies is entering a pivotal phase of growth-expanding our PET radiopharmaceutical footprint and investing significantly in next-generation manufacturing capabilities to bring critical diagnostic solutions closer to patients.

This is a unique opportunity for a leader in medical isotope manufacturing to shape the future of PET operations at scale. As we grow our network of cyclotron-enabled facilities and advance new radiopharmaceutical products, we are looking for someone who can combine deep technical expertise in isotope production with strong, people-first leadership.

In this role, you won't just maintain operations-you will build, scale, and standardize across a rapidly evolving manufacturing network. You'll lead experienced teams, elevate quality culture, and drive operational excellence in an environment where precision, speed, and compliance directly impact patient care.

Key Responsibilities

• Lead PET radiopharmaceutical manufacturing operations across multiple sites, ensuring compliance with FDA 21 CFR Parts 211/212 and all applicable cGMP regulations
• Direct cyclotron and isotope production operations (e.g., F-18, Ga-68), including maintenance planning and reliable supply of short-lived radioisotopes
• Foster a strong quality culture by reinforcing GMP documentation practices, data integrity (ALCOA+), and inspection readiness across all locations
• Serve as the lead for FDA inspections, regulatory audits, and internal audits; oversee responses, CAPAs, and ongoing compliance efforts
• Partner with Quality Assurance and Regulatory Affairs to maintain licenses, support NDA/ANDA/IND activities, and ensure compliance with USP, NRC, and state radiation control regulations
• Drive operational performance through KPIs (OEE, yield, cycle time, right-first-time), root cause investigations, and continuous improvement initiatives
• Lead, mentor, and develop multidisciplinary teams including manufacturing leaders, cyclotron engineers, radiochemists, and technicians
• Oversee production planning, supply chain coordination, capital projects, and equipment qualification (IQ/OQ/PQ) to support growth and reliability

Qualifications

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Nuclear Engineering, or related life science field
• Minimum 8 years of pharmaceutical or radiopharmaceutical manufacturing experience, including cyclotron operations and PET drug production
• At least 4 years in a people leadership role, with demonstrated success leading technical teams in regulated environments
• Strong working knowledge of FDA regulations (21 CFR Parts 211/212), cGMP, and quality systems, including deviations, CAPAs, and change control
• Experience with radiopharmaceutical synthesis, process validation, and technology transfer in PET manufacturing settings
• Preferred: Radiation Safety Officer (RSO) certification, Authorized User (AU), or PMP certification

Why Join Us

We offer competitive compensation, an annual performance bonus, generous vacation, and 401K matching.

Inclusion & Equal Opportunity

Jubilant Radiopharmacies is proud to be an equal opportunity employer. We are committed to building a diverse and inclusive workforce where all employees feel valued, respected, and empowered to contribute. We welcome applicants from all backgrounds and provide reasonable accommodations to support individuals with disabilities throughout the hiring process.

APPLY NOWFORWARD TO A FRIENDSAVE JOB

Having trouble applying for this job? Please contact us via email at it.helpdesk@jubl.com

Job Overview

DATE POSTED :

24/06/26 LOCATION :

Home Based COMPANY :

Jubilant DraxImage, Inc. dba Jubilant Radiopharma FUNCTION :

Manufacturing

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