Associate Director| External Manufacturing Operations

Job highlights
Identified by Google from the original job post
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
Ability to express oneself clearly and concisely by adjusting style, language, and/or terminology as appropriate based on audience
Experience in commercialization of new assets, through launch, and management of post-approval changes
Demonstrated ability to build strong cross-functional collaborations and act as a member and leader of teams
Ability to travel on an as-needed basis
Responsibilities
We are seeking an Associate Director, External Manufacturing (EM) Operations responsible setting direction and priorities for Lantheus’ external manufacturing operations and is accountable for meeting commercial production and budget goals while advancing the continuous improvement in areas of Quality, Cost, and Service
Works closely with other departments to prioritize activities that impact production
Implement, maintains, and supports all corporate policies and procedures
Communicates effectively internally and externally to share operational and company information; maintains operations in full cGMP compliance following all relevant Federal, State, and local laws and regulations
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
Drive business process improvement projects and commercialization initiatives for EM via cross-functional matrix teams, partnering to identify improvement areas with a focus on business process scalability, network strategy, reliability, and cost effectiveness
Partner with key stakeholders (e.g
Supply Chain Planning, Quality, Manufacturing Technology & Development, Finance, Procurement, and IT) and ensure that business processes for EM integrate effectively with the end-to-end manufacturing and supply chain processes established within Lantheus
Leverage breadth of professional experience to drive both internal stakeholders and suppliers to execute operational workflows and plans
Partner 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, identify lessons learned and best practices to be implemented across suppliers
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 VSOTs
Partner with cross-functional operating teams 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
Job description
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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.

We are seeking an Associate Director, External Manufacturing (EM) Operations responsible setting direction and priorities for Lantheus’ external manufacturing operations and is accountable for meeting commercial production and budget goals while advancing the continuous improvement in areas of Quality, Cost, and Service. Works closely with other departments to prioritize activities that impact production. Implement, maintains, and supports all corporate policies and procedures. Communicates effectively internally and externally to share operational and company information; maintains operations in full cGMP compliance following all relevant Federal, State, and local laws and regulations.

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
• Drive business process improvement projects and commercialization initiatives for EM via cross-functional matrix teams, partnering to identify improvement areas with a focus on business process scalability, network strategy, reliability, and cost effectiveness. Partner with key stakeholders (e.g. Supply Chain Planning, Quality, Manufacturing Technology & Development, Finance, Procurement, and IT) and ensure that business processes for EM integrate effectively with the end-to-end manufacturing and supply chain processes established within Lantheus.
• Leverage breadth of professional experience to drive both internal stakeholders and suppliers to execute operational workflows and plans. Partner 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, identify lessons learned and best practices to be implemented across suppliers.
• 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 VSOTs.
• Partner with cross-functional operating teams 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
• Persona example: This position is site-based in Billerica/Bedford, MA.

Other Requirements
• Ability to express oneself clearly and concisely by adjusting style, language, and/or terminology as appropriate based on audience
• Experience in commercialization of new assets, through launch, and management of post-approval changes
• Demonstrated ability to build strong cross-functional collaborations and act as a member and leader of teams
• 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, ****** orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.

United States
Massachusetts
Billerica Show on map Get directions