Technology Transfer Lead

- 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

Orano Med is seeking a detail-oriented Technology Transfer Lead for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals.

The Technology Transfer Lead will define the strategy and implement the framework for technology transfers of radiopharmaceutical products developed within Orano Med. Lead technology transfer projects between Orano Med sites, overseeing activities for both sending and receiving sites, in collaboration with all involved departments (Chemistry, Manufacturing, and Controls, Quality, Regulatory, MS&T and Operations) including:

Responsibilities

- Project scoping: formation of the project team, timeline definition, specific cost assessment, and establishment of prerequisites and deliverables.

- Drafting and approval of technology transfer protocols (including analytical method transfer) as well as defining the validation strategy for implementing new processes.

- Conducting risk analyses and developing mitigation strategies, including cleaning validation and cross-contamination risk management.

- Monitoring project timelines and deliverables, reviewing generated documentation to ensure completeness and compliance with project needs.

- Assessing facility readiness and operational preparedness.

- Providing technical support and troubleshooting during site transfers, including root cause analysis of process deviations or anomalies.

- Ensuring full documentation traceability and robustness to guarantee regulatory compliance and industrial reproducibility.

- Addressing radiological safety risks in coordination with local Health, Safety, and Environment representatives.

- Manage outsourcing projects to Contract Manufacturing Organization/Contract Development and Manufacturing Organization partners for Active Pharmaceutical Ingredient (peptide or other) manufacturing, defining, and overseeing Chemistry, Manufacturing, and Controls requirements with external suppliers or partners.

- Prepare for and support audits and inspections (including health authorities’ inspections) related to technology transfers.

- Implement and promote best practices in technology transfer, capturing, and sharing lessons learned across the organization.

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

- Master’s degree in Engineering or PHD in Pharmacy, Chemistry, Bioprocessing Radiochemistry, or Chemical Engineering

Experience

- 5+ years of experience in the pharmaceutical or biotechnology industry, ideally within the radiopharmaceutical or sterile injectable field.

- Chemistry, Manufacturing, and Controls activities and preparation of quality/GMP documentation.

- Technology transfer to GMP sites (scale-up, validation, qualification).

- Pharmaceutical development of injectable products, from early-stage clinical phases through to registration.

- Close collaboration with Quality, MS&T, and support functions (Regulatory Affairs, R&D, Health, Safety, and Environment).

- Chemistry, Manufacturing, and Controls interface management with external partners (industry or biotech companies).

- Strong attention to detail and organizational skills.

- Excellent written and verbal communication skills.

- Ability to work independently and collaboratively in a team environment.

Please Note: The provided salary information is a guideline. Your offered salary is based upon experience, qualifications, geographic location, as well as market and business considerations.

Salary range annually: $140,000 - $180,000

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.