Associate Director, Manufacturing Technical Services

Associate Director, Manufacturing Technical Services

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

This position is site-based and requires a presence on-site five days per week.

Summary

We are seeking a highly motivated and experienced individual to lead the Manufacturing Technical Services team at our Lantheus Billerica manufacturing site. This role is critical to ensuring the efficient and compliant operation of our GMP manufacturing facilities by providing both tactical and strategic equipment and maintenance support. The Associate Director will champion a culture of continuous improvement, foster strong cross-functional collaboration, and drive the identification and resolution of systemic issues impacting safety, quality, and plant performance. Reporting to the Sr. Director Manufacturing Engineering, this leader will be responsible for building a high-performing team (the Process Support Team), optimizing utility and process equipment infrastructure in a radiopharmaceutical manufacturing facility, and establishing robust business processes to support operational excellence.

Key Responsibilities / Essential Functions

Team Leadership and Development :

o Lead a highly capable team of up to 12 technical professionals and technicians, fostering a culture of teamwork, engagement, and continuous improvement.

o Provide coaching, mentorship, and performance management to support individual and team growth and development.

Operational Excellence and Technical Expertise :

o Lead complex equipment troubleshooting efforts, empowering the team with comprehensive troubleshooting skills and equipment knowledge.

o Optimize and oversee the implementation of robust equipment maintenance programs for process equipment and GMP utilities, ensuring high reliability and on-time compliance Utilize the CMMS (Computerized Maintenance Management System) to effectively and compliantly execute both GMP and non-GMP planned maintenance (e.g. Return to service activities, job plan creation, maintenance plan assignments, and spare parts management).

o Demonstrate and instill in the team a strong commitment to GMP compliance, particularly regarding documentation of work and leveraging site change management procedures.

o Manage the Process Support department activities to ensure quality, cost, and customer service goals are achieved.

o Drive excellence in all aspects of day-to-day process support for GMP Manufacturing operations.

Quality and Compliance :

o Actively promote a safety-first culture and ensure adherence to all safety rules and best practices.

o Support investigations of equipment / technology-based quality events, leading CAPA implementations.

o Collaborate with the Quality department to ensure compliance with relevant regulatory requirements, including FDA regulations and cGMP guidelines. A working knowledge of TrackWise QMS is preferred.

Strategic Planning and Collaboration :

o Identify and address systemic issues impacting operations, coordinating cross-functional responses.

o Build and maintain strong relationships with key stakeholders, including Manufacturing, Quality, Finance, Facilities, Automation / Engineering, and EHS.

o Communicate technical information effectively across all levels of the organization and to external stakeholders.

o Support the development and implementation of the site's strategic plan and long-term business development plan, incorporating Digital Technology initiatives.

Continuous Improvement :

o Drive continuous improvement initiatives to enhance production efficiency, safety, and quality.

o Implement Lean Manufacturing principles and utilize problem-solving methodologies to resolve issues and optimize processes.

o Manage projects related to process control, yield optimization, and product quality improvements.

Typical Minimum Skills and Experience and Education

Bachelor's degree in Engineering, Science, or equivalent experience.

10+ years of relevant experience supporting / maintaining equipment in a regulated GMP manufacturing facility.

Other Requirements

Experience leading technical teams and driving successful project execution.

In-depth knowledge and experience with GMP Utilities, Radioactive (hot) Manufacturing Processes and Principles, and Label-Pack operations including custom automated manufacturing skids.

Strong understanding of CMMS functionality, including job plan creation, maintenance plan assignments, and spare parts management. A strong working knowledge of Maximo is preferred.

Familiarity with predictive maintenance models and principles.

Excellent written and verbal communication skills, including the ability to write and review technical documents.

Experience interacting with FDA and other regulatory agencies.

Proven ability to build strong relationships and influence stakeholders across functional groups.

Demonstrated problem-solving skills and the ability to find innovative solutions to complex issues.

Core Values

The ideal candidate will embody Lantheus core values :

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone's health is in our hands
• Own the solution and make it happen

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law.