Sr. Project Manager - Radiopharmaceutical

Orano Med, LLC.
life insurance, vision insurance, paid time off, 401(k)
United States, Indiana, Brownsburg
1145 East Northfield Drive (Show on map)
Dec 09, 2025
Job description The Sr. Project Manager - Radiopharmaceutical Business Objectives will be responsible to lead business-critical projects at our ATLab Indianapolis site. In addition to managing projects, this role will play a key part in ensuring that the facility and process design are aligned with CMC development and regulatory requirements, particularly for the IND submission, upcoming Phase III clinical studies, NDA submission, and FDA Pre-Approval Inspection (PAI). The Sr. Project Manager will report to Director of Operations, NA. This role requires strong leadership in project management, but also the ability to partner with Quality, Regulatory, CMC, and Manufacturing teams to ensure the facilities and processes meet clinical and commercial readiness expectations. Key Responsibilities Partner with CMC, Quality, Regulatory Affairs, Safety, and Manufacturing teams to ensure the site is poised to support clinical trial and commercial production requirements. Coordinate all projects pertaining to technology transfers, new product introductions, and Phase III/commercial production. Anticipate regulatory and validation requirements for both clinical and commercial supply, ensuring our site is inspection ready. Develop mitigation plans for risks and gaps in project execution. Drive the governance, knowledge management, and continuous improvement for projects linked to Phase III and commercial production. Our Full-Time Benefits Competitive compensation Health, Dental, and Vision insurance - with generous employer contributions 401(k) with employer matching and contribution amounts Life insurance and Short- and Long-Term Disability insurance provided by the company Generous Paid Time Off and holiday schedules Numerous Training and Development opportunities and more... Ideal qualifications Qualifications Required Education Bachelor's degree in Pharmaceutical Engineering, Mechanical, Electrical, Process Engineering, or a related field. Experience Minimum of 10 years of experience in a (radio) pharmaceutical, nuclear, or other complex process environment. Minimum of 5 years of direct project management experience. Solid understanding of: Design and qualification of GMP-compliant equipment. Operation of hot cells and critical systems within the pharmaceutical industry. Facility layout and infrastructure supporting aseptic manufacturing operations. CMC requirements and regulatory expectations for clinical and commercial radiopharmaceutical manufacturing. Strong rigor and attention to details Effective project management skills Proven ability to collaborate with multi-disciplinary teams Solution-oriented and field-driven mindset Capable of driving projects forward in a fast-paced, evolving environment. Location & Travel Location: Brownsburg, Indiana (onsite leadership role) Ability to travel as needed (domestic and international) Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law.