Senior PET Manufacturing Process Engineer

Lantheus; Bedford (MA); On-site; USD 90,000 - 140,000; Full time

Job summary

An established industry player is seeking a qualified candidate to provide technical support for Commercial and Clinical Operations. This role emphasizes leadership and technical expertise, ensuring compliance with industry regulations and quality standards. You'll be involved in validation activities, troubleshooting, and continuous improvement within the PET Manufacturing Facility network. If you have a strong background in science or engineering, along with proven managerial skills, this is a fantastic opportunity to contribute to enhancing patient care through innovative medical imaging solutions.

Qualifications

• 7+ years of industry experience in technical operations or PET manufacturing.
• Proven leadership and experience working cross-functionally.

Responsibilities

• Represent Technical Operations for projects and assess manufacturing processes.
• Support Regulatory Affairs with IND and NDA submissions and audits.

Skills

Leadership

Technical Writing

Project Management

Communication

Troubleshooting

Education

Bachelor's or Master's in Science or Engineering

PhD in relevant field

Tools

Project Management Tools

Job description

Lantheus, headquartered in Bedford, Massachusetts, with offices in New Jersey, Canada, and Sweden, has been a pioneer in medical imaging for over 60 years. The company offers a broad product portfolio that includes diagnostics, therapeutics, and AI solutions, aiming to enhance patient care.

We are seeking a qualified candidate to provide technical support for daily Commercial and Clinical Operations, participate in validation activities, PET CMO qualification initiatives, troubleshooting, and continuous improvement within our PET Manufacturing Facility network. The role involves leadership and technical expertise, ensuring compliance with industry regulations, quality standards, and regulatory frameworks.

Key Responsibilities

1. Represent Technical Operations for projects, assess manufacturing processes, and review technology transfer plans at PET CMO sites.
2. Support Regulatory Affairs with IND and NDA submissions, inspection readiness, and audits.
3. Support intellectual property procedures.
4. Maintain oversight of PET CMO sites for compliance, lead technical visits, support investigations, and drive continuous improvement projects.
5. Provide technical expertise in review meetings and develop metrics related to PET CMOs and suppliers.
6. Collaborate across departments to build relationships and contribute to a high-performance culture.
7. Coach and evaluate team members, enhancing team capabilities and performance.
8. Demonstrate core values of accountability, collaboration, customer service, quality, efficiency, and safety.

Basic Qualifications

1. Bachelor's or Master's in science or engineering with over 7 years of industry experience, or PhD with over 5 years, including GMP experience; PET manufacturing experience is preferred.
2. Proven leadership and managerial skills, experience working cross-functionally, and managing vendors.

Other Requirements

1. Deep knowledge of the scientific field.
2. Strong decision-making skills in complex situations.
3. Experience managing complex projects, familiarity with project management tools.
4. Excellent communication and technical writing skills.
5. Experience in a fast-paced PET production environment and troubleshooting skills.
6. Willingness to travel approximately 10-20%, including international trips.

Lantheus is an equal opportunity employer, committed to non-discrimination and reasonable accommodations for individuals with disabilities. Applicants requiring accommodations should contact [e-mail].

For more information on employment rights, review the Know Your Rights notice from the Department of Labor.