Director, Radiopharma Technology Strategy and Operations

Job Description Summary
The Director, Radiopharma Technical Strategy & Operations will play a pivotal role in providing high-level scientific and technical leadership within the Manufacturing Sciences and Technology (MSAT) team. This position reports directly to the Head of MSAT and is responsible for driving innovation, technical strategy, and process optimization for the radiopharmaceutical manufacturing operations, particularly in the PET radiotracer space. With deep expertise in radiochemistry, process development, and global manufacturing operations, the Senior Director will bridge the gap between research, development, and large-scale production, ensuring operational excellence while providing guidance on the technical aspects of manufacturing processes. Additionally, this role will provide crucial support for business development efforts related to the optimization and utilization of the Arlington Heights facility, with a focus on leveraging equipment and capabilities to explore and expand into the broader radiotherapeutics sector.

Job Description
Roles & Responsibilities:

Technical Leadership and Innovation:

• Provide strategic technical direction in the radiopharmaceutical manufacturing space, focusing on radiochemistry, process development, and cutting-edge technologies that impact production efficiency and product quality.
• Lead the technical strategy for new product development, scalable manufacturing, and advanced radiopharma processes.
• Act as the subject matter expert on radiochemistry, ensuring that scientific advancements and technical innovations are integrated into the company's manufacturing processes.
• Lead and advise on the development and optimization of radiotracers, ensuring that processes meet both scientific and regulatory standards.

Collaboration with Head of MSAT:

• Partner with the Head of MSAT to align the operational execution of manufacturing with long-term strategic goals, ensuring that innovations in radiopharma manufacturing are seamlessly integrated into daily operations.
• Provide technical expertise to the MSAT team in troubleshooting complex radiochemistry issues, guiding improvements in production processes where technical expertise is required.
• Support the Head of MSAT in problem-solving and decision-making for manufacturing challenges, particularly those that involve technical or scientific barriers.

Business Development Support:

• Collaborate with business development teams to identify and optimize opportunities for utilizing the Arlington Heights facility, ensuring that equipment and manufacturing capabilities are leveraged to expand into the broader radiotherapeutics field.
• Work closely with leadership to develop strategies that align operational and technical capabilities with business development goals, ensuring optimal utilization of existing resources to drive business growth.
• Support business development activities by providing technical assessments, market insights, and innovative strategies for entering new therapeutic areas, particularly in radiotherapeutics, and other emerging sectors.
• Provide strategic input on the development and scale-up of manufacturing processes aimed at supporting commercial entry into new radiotherapeutic markets.

Global Manufacturing & Tech Transfer:

• Help support and oversee global tech transfer activities related to radiopharmaceutical manufacturing, ensuring seamless transitions from research and development to commercial production.
• Provide technical guidance on scaling up production processes at internal and external manufacturing sites, ensuring the technology is successfully integrated into larger-scale operations.
• Collaborate with external partners, including contract manufacturers, radiopharmacies, and CMOs, to ensure high standards in manufacturing processes and product quality.

Operational Excellence and Process Optimization:

• Work with the Head of MSAT to identify opportunities for process optimization, utilizing your technical expertise to suggest innovations that drive efficiency, reduce production costs, and improve overall product yield.
• Support troubleshooting activities for complex technical issues, particularly those related to radiotracer production and advanced manufacturing technologies.
• Act as a key advisor in resolving complex technical problems that may arise during the manufacturing process, guiding the MSAT team in developing corrective actions.

Regulatory Compliance & Risk Management:

• Ensure that radiopharmaceutical manufacturing processes adhere to regulatory requirements, including 21 CFR 212, FDA regulations, and Board of Pharmacy standards.
• Support quality assurance and regulatory compliance efforts by offering technical leadership on documentation, validation protocols, and technical aspects of product risk assessments.
• Participate in audits and inspections, particularly with regard to the radiochemistry aspects of manufacturing and production.

Mentorship and Team Development:

• Mentor and develop junior staff and MSAT team members, providing technical guidance and fostering a culture of continuous learning in the field of radiopharmaceutical manufacturing.
• Support the Head of MSAT in building a cohesive and high-performing team by contributing to training and skills development in radiopharmaceutical manufacturing processes.

Required Qualifications:

Education:

• PhD in Radiochemistry, Chemistry, Pharmaceutical Sciences, or a related field.

Experience:

• 10+ years of experience in the radiopharmaceutical, biotech, or pharmaceutical industries, with a focus on radiochemistry, process development, and manufacturing operations.
• Proven experience in leading technical teams in radiopharma manufacturing, with expertise in process development, scaling up, and tech transfers.
• Hands-on experience with advanced manufacturing technologies and troubleshooting in the production of radiotracers or other radiopharmaceuticals.
• Strong background in regulatory compliance, including FDA regulations (21 CFR 212), GMP standards, and other pharmaceutical regulations.
• Demonstrated experience or capability to support business development initiatives, particularly in optimizing existing facilities to tap into new markets (e.g., radiotherapeutics).

Desired Qualifications:

Skills:

• Expertise in radiochemistry, process optimization, and manufacturing technologies within the radiopharmaceutical space.
• Strong leadership, collaboration, and interpersonal skills, with the ability to influence and engage stakeholders across functions.
• Proven ability to provide technical guidance to operational teams, mentoring junior staff and ensuring the implementation of best practices.
• Demonstrated success in global tech transfers and managing external manufacturing partnerships.
• Excellent problem-solving, critical thinking, and troubleshooting skills.

Personal Attributes:

• A strategic thinker who is comfortable balancing operational needs with long-term technical innovation.
• Detail-oriented with a passion for maintaining the highest standards of quality and compliance in radiopharmaceutical manufacturing.
• A collaborative mindset, with the ability to work across departments, bringing technical expertise to both operational and strategic discussions.
• A proactive approach to continuous learning, innovation, and improvement in radiopharma processes.

Additional Information:

• This position may require occasional travel to external manufacturing sites or other relevant locations.
• The role will involve close collaboration with the Head of MSAT, but with a strong emphasis on technical leadership, innovative strategies for advancing radiopharmaceutical manufacturing, and supporting business development efforts to expand into the radiotherapeutics field.

For U.S. based positions only, the pay range for this position is $164,560.00-$246,840.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No