Associate Director, External Manufacturing Operations

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. In 2023, Lantheus had more than $1B in revenues, led by sales of imaging agents for cardiac ultrasound and for prostate cancer.

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.

Summary of role

Responsible for the operational performance, financial performance, and program management of initiatives occurring at sites within the External Manufacturing (EM) network. This role will partner with cross-functional teams, both internal and external, to ensure operational milestones supporting network expansion and strategic initiatives are met, and supply to patients is uninterrupted. Ensures adherence to governance processes and information flow between the EM network and internal partners.

The role sponsors business process improvement projects for EM via cross-functional matrix teams, partnering to identify areas for improvement with a focus on business process scalability, reliability, and cost effectiveness. This role partners with key stakeholders (e.g. Supply Chain Planning, Quality, Manufacturing Technology & Development, Finance, Procurement, and IT) and ensures that business processes for EM integrate effectively with the end-to-end manufacturing and supply chain processes established within Lantheus.

This is a leadership role comprising a breadth of professional experience and the drive to work with both internal stakeholders and suppliers to execute operational workflows and plans. She/he partners across the Technical Operations matrix, with Quality and other enabling functions, to remove barriers to successful production management. With an enterprise view and focus on supply continuity, she/he identifies lessons learned and best practices to be implemented across suppliers.

In this capacity, the role acts as the relationship lead and the primary point of contact with the external manufacturer for supplier governance and management. She/he is ultimately responsible for the performance and successful execution of the manufacturing operations at the external manufacturing site.

This role supports the supplier contracting process across EM via best practices to ensure business needs, reliable delivery, and performance requirements are met. This role also drives operational budgets for EM and ensures execution in accordance with financial plans.

Key Responsibilities/Essential Functions

• Lead and facilitate the execution of process improvements, EM network expansion, and product life-cycle changes for externally manufactured products, deploying best practices in project/program management.
• Facilitate the EM Tier Management process (e.g. vSLT, Tiered meetings, etc.) to ensure principle adherence. Lead identification of issues, lessons learned, and best practices across the network for areas within scope.
• Design and implement flexible workflows to support rapid external responses considering the dynamics of radiopharmaceutical manufacturing operations.
• Facilitate EM Business/Performance Reviews focused on EM business performance drivers; ensure information flow within the EM network and internal stakeholders.
• Partner with internal stakeholders to identify improvement opportunities focusing on business process scalability, network strategy, reliability, and cost effectiveness. Lead business process improvement projects for EM via cross-functional matrix teams.
• Develop and maintain strong strategic relationships with supplier to ensure optimal outcomes, both immediate and long term. Partner with supplier to provide operational production and project execution oversight for manufacturing. Facilitate prioritization and execution of manufacturing operations and plans.
• Develop and maintain supplier contract expertise; serve as contract monitor. Ensure supplier is leveraging best practices to provide reliable supply, minimize costs, and satisfy performance requirements in alignment with contractual agreements.
• Develop EM operating budgets and ensure execution to financial plan.
• Drive network strategy processes and governance.
• Provide support for investigations, change controls, deviation management, and CAPA implementation as required.
• Partner with internal stakeholders and suppliers to support business continuity and risk management initiatives

Basic Qualifications

• Proven experience in implementation of strategic initiatives in a dynamic business environment, a solid technical operational background, and an understanding of the challenges and impacts of identifying, selecting, qualifying, and managing external manufacturing partners
• Demonstrated success in a matrixed cross-functional organization with a high level of independence and empowerment to deliver against strategic program goals
• Ability to adapt to risks/changes associated with novel technologies and distill trade-off decisions into recommendations for escalation to leadership/negotiation with suppliers to meet program objectives
• Bachelor's degree in engineering, life sciences, or related discipline
• > 10 years of experience working in a regulated (bio)pharmaceutical manufacturing, supply chain, or pharmaceutical development with at least three years of experience in manufacturing operations and/or external manufacturing

Other Requirements

• Ability to express oneself clearly and concisely by adjusting style, language, and/or terminology as appropriate based on audience
• Project management experience
• Experience in commercialization of new assets, through launch, and management of post-approval changes
• Ability to travel on an as-needed basis

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States.