Sr. Project Manager - Radiopharmaceutical

- Regular/Permanent

- USA / Indiana

- In Office

Welcome to Orano

Helping to meet current and future challenges to preserve our world and build the world of tomorrow while taking care of everyone's health is stimulating for you. For us too. By joining the Orano Group, a leading international player in the nuclear industry, you are in the right place.

Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.

Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 17,000 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.

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.