Associate Director, MSAT

Role Summary

The Associate Director, MSAT acts as a technology development and transfer lead in the Manufacturing Technology and Development (MT&D) organization. This role is responsible for the technical work between internal and external stakeholders to ensure design, development, and transfer of robust manufacturing processes for new products and key lifecycle injectable PET radiopharmaceutical finished products. It serves as the principal expert and process owner for the end-to-end manufacturing process for injectable PET radiopharmaceutical finished products, ensuring processes are designed and validated per applicable cGMPs and regulatory filings. The role requires on-site presence in Massachusetts three days per week and is open to applicants authorized to work for any employer within the United States.

Responsibilities

• Leads technology development and transfer projects for key lifecycle injectable PET radiopharmaceutical products, establishing process/parameters for each unit operation up to process performance qualification and subsequent CMC filing activities.
• Leads a team of engineers/scientists to execute development, characterization, optimization, and troubleshooting of manufacturing processes for PET radiopharmaceutical products.
• Leads DoE and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies (PCS).
• Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental plans, or templates; creates, maintains, and harmonizes tech transfer processes with internal and external stakeholders.
• Partners with R&D and internal/CMO management to identify best practices in industry related to technology transfers and pharmaceutical technology.
• Partners with Business Development to identify/evaluate new platforms and pipeline products; collaborates cross-functionally to assess demand, network capacity, and implement/improve site activations or processes to meet demand.
• Partners with site operations to provide a sustainable radiopharmaceutical manufacturing process; incorporates lessons learned across network sites for optimization.
• Leads, motivates, mentors, and develops team members to exceed MT&D and company goals.
• Maintains effective working relationships with other divisions and external partners for technology transfer, validation, and process support.
• Reviews and co-authors key CMC sections with external partners and cross-functional stakeholders.
• Requires approximately ~20% travel.
• Promotes safety and compliance with protective equipment; identifies and corrects safety/environmental hazards.
• Demonstrates Lantheus values in daily work.

Qualifications

• Required: B.S. or M.S. in a relevant scientific/technical discipline; advanced degrees (e.g., PhD) or certificates preferred but not required.
• 10+ years in pharmaceutical or medical device industry; 5+ years in technology development and transfer within a matrixed organization.
• Experience with aseptically filled/finished drug products, medical devices, radiopharmaceuticals, and CMO management strongly preferred.

Other Requirements

• SME in PET radiochemistry/radiotracer development, including automated synthesis/production and analytical method development; experience with radiotracer production validation.
• SME in PET radiopharmaceutical production operations, including CMO/PMF management; ability to translate projects from development to production.
• SME in parenteral operations: aseptic processing, sterilization, sterile filtration, isolator technology; knowledge of global regulatory requirements for these processes.
• Knowledge of USP 823 and 21 CFR 212 regulatory requirements for clinical and commercial PET radiopharmaceutical manufacturing.
• Track record of regulatory filings and success with CMC (IND Module 3) writing/editing.
• Knowledge of SOPs, cGMPs, GLPs; ability to work within a regulatory environment.
• Experience executing technology transfer and scale-up programs for commercial drug product manufacturing.
• Ability to lead cross-functional technical teams; familiarity with DoE, Quality by Design, and Quality Risk Management in pharmaceutical manufacturing; experience with a quality management system.
• Experience with project management systems/tools; excellent organizational skills and ability to manage multiple technical projects.
• Ability to work in a dynamic environment; strong leadership, mentoring, and people development skills; proactive collaboration and negotiation abilities.
• Prior experience leading interdisciplinary or cross-functional pharmaceutical/biotech teams; understanding of FDA/EMA quality/regulatory processes; regulatory filing experience desired.
• Experience working with external partners is desirable.
• Ability to work independently, resolve obstacles, and exercise independent judgment; strong attention to detail and ability to see the big picture.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project; professional integrity and professionalism in external interactions.
• Travel as required by product needs and project deliverables, including overnight travel to Lantheus and CMO locations.

Education

• Not specified beyond above qualifications.

Additional Requirements

• Lantheus core values alignment and ability to operate in a health-focused, results-driven environment.