Lantheus

Title: Supplier Quality Senior Specialist Location: Bedford United States Hybrid Job Description: Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands. Summary of role The Supplier Quality Senior Specialist is responsible for maintaining Lantheus’s Supplier Quality Management (SQM) program, ensuring that systems, processes and procedures between Quality, Supply Chain, Technical Operations and R&D are compliant and aligned with business needs. This Senior Specialist is responsible for acting as the primary point of contact and relationship manager for Third Party Logistics (3PL) and Pharma Partners. They are also responsible for developing and managing an Approved Vendor List and ensuring procedures are in place for supplier lifecycle management, including initial assessment, qualification and onboarding, monitoring and offboarding, with continuous improvement initiatives. Domestic and international suppliers consist of Contract Manufacturing Organizations (CMO), drug substance precursors, active pharmaceutical ingredient (API) providers, raw material and component suppliers, contractors, 3PL and service providers. The Supplier Quality Senior Specialist oversees supplier performance on an ongoing basis, implements a program of monitoring and continuous improvement and, if necessary, eliminate suppliers from the approved vendor list. This Senior Specialist executes all actions that contribute to the success of maintaining a compliant vendor management program. They also maintain oversight and execution of all assigned Corrective and Preventative actions related to Supplier Quality management. The position can be either remote or hybrid, with occasional onsite requirements at the department location in Bedford, Massachusetts. Key Responsibilities/Essential Functions - Adhere to existing supplier lifecycle management program to ensure appropriate controls, processes and procedures are developed, implemented and maintained to ensure full compliance with regulatory requirements and alignment with industry best practices. - Serve as primary point of contact for 3PL and Pharma Partners. - Own and manage 3PL/Pharma Partner relationships; attend and/or own periodic touchpoints. - Support external audit planning, including risk-based execution and observation remediation. - Oversee supplier performance and quality data sources and metric reporting to identify quality issues and trends, as well as implement corrective actions and effectiveness criteria to hold suppliers accountable to promised performance improvement plans. - Own and resolve supplier-related deviations and CAPAs relating to non-conforming materials and services to identify true root causes and drive timely closure with suppliers. - Oversee supplier change management program, ensuring cross-functional participation and timely implementation to meet compliance standards and business needs. - Serve as Quality lead for new vendor triage process and provide Supplier Quality review of new material setup in GxP systems - Support disposition of discrepant, damaged, or expired supplier materials as - Assure planned changes to supplier management processes are fully approved and compliant with Lantheus procedures and regulatory guidelines. - Develop and maintain a strong partnership with key suppliers and act as the primary conduit for quality related issues from suppliers, contractors and consultants. Partner with Procurement and R&D, at an early stage, to identify development as well as commercial suppliers and contractors for new product introduction programs and redundancy in supply. - Act as the primary Quality representative for supplier management projects to support cost control programs, inventory management planning and compliance and business risk mitigation programs. - Ensure adherence to supplier quality management budget plan - Function as an internal consultant and resource for site training/education coordination needs, including providing leadership and information to operations. - Serves as Subject Matter Expert for internal Committees and Boards as required in support of supplier management as determined by business need. Basic Qualifications - Requires a BS degree in a scientific discipline and minimum of 7+ years’ experience in a GMP environment, preferably in a Quality- related discipline or Supplier Quality Management within the Pharmaceutical, Biotech and /or Medical Device industry, or equivalent combination of education and experience. - Incumbent must have excellent written, verbal and presentation skills. Must be able to interact effectively with all levels of management, both internal and external. - Must have a good understanding of cGMP requirements by FDA, EMA, ICH Q8, 9 and 10. - Must have demonstrated experience with Quality Management System databases. - Requires the ability to work independently to own projects and execute to 100% completion with minimal supervision. - Strong negotiating and collaboration skills are essential; incumbent must be able to influence and drive suppliers to high levels of performance. Other Requirements - Travel to suppliers (about 25%) will be required based on business needs. - Strong understanding of principles of Analytical/Chemistry required to support Supplier Analytical Testing and method development preferred but not required. 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 The pay range for this position is between $111,000 and $185,000 annually. Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave.

• Oversee and enhance the effectiveness of commercial field teams • Partner with Field Leadership to develop strategy, execution plans and support ongoing measurement/progress tracking for product specific initiatives • Understand the unique needs and challenges of each business division and offer insights and potential solutions to meet business objectives • Collaborate with cross-functional teams to identify areas for improvement, develop strategies to build capabilities, and implement effective solutions to drive commercial organizational success • Develop and implement best practices, methodologies, and tools to enhance efficiency, effectiveness, and collaboration • Facilitate communication and collaboration between teams, ensuring a shared understanding of goals, priorities, and progress • Implement change management strategies and plans to support successful execution of national account transformation initiatives • Act as a change agent, promoting a culture of continuous improvement and innovation across the company • Ensure alignment between marketing efforts and sales strategies • Monitor industry trends, competitive landscape, and market dynamics to provide insights to Executive Leadership • Collaborate with the sales team to develop joint marketing programs and promotions to drive national account engagement and achieve sales targets • Demonstrate and employ the judgment, flexibility and situational leadership required to lead through complex combinations of market challenges, including business and organizational change necessitated by changes in the medical, regulatory, and business environment

• Develop and execute commercial partnership strategies that drive growth and maximize profitability. • Collaborate with a cross-functional team representing the Lantheus portfolio of radio diagnostic and therapeutic products. • Oversee business-to-business relationships with PET manufacturing organizations and radiopharmacies. • Monitor and analyze channel performance, including sales data and customer feedback. • Negotiate agreements with internal/external leadership critical to the attainment of organizational objectives.

• Serve as market access account lead for major IDNs, large groups and large academic institutions. • Build sustainable collaborations for health systems against shared priorities/common interests to deliver long-term value and drive portfolio growth through strategies designed to maintain or improve brand access. • Manage and coordinate resolution of reimbursement issues by collaborating with internal Lantheus teams and respective imaging center/hospital staff. • Identify, develop, and execute business opportunities by focusing on appropriate positioning and messaging of Lantheus products within assigned and customer segments. • Proactively identify and resolve any potential issues and challenges in collaboration with cross-functional partners. • Execute Market Access educational programs in respective region where applicable. • Drive quarterly business reviews in large population health accounts. • Develop and implement strategies and tactics to support patient access, coverage, coding, and payment in assigned accounts. • Drive brand growth through strategies designed to maintain or improve brand access. • Build relationships with and implement market access strategy with key hospital and imaging center personnel. • Coordinate and communicate with other commercial functions to ensure all market access needs are met across the organization. • Serves as a strategic partner sharing business insights on accounts and market trends.

• Responsible for the relevance and accuracy of clinical development planning and guidance for a clinical study. • Contribute to authoring and lead design/reviews of key product and study-related documents and deliverables. • Responsible for the oversight of clinical study execution as clinical lead. • Works with investigative sites and/or study teams to answer protocol related questions. • Reviews clinical data listings, patient profiles and summaries to ensure data collection, data interpretation and data reporting proceeds in a manner consistent with the protocol. • Prepare and may present protocol designs, clinical data and other information at advisory boards, investigator meetings, site initiations and other internal and external settings. • Supports regulatory interactions and the development of clinical sections for regulatory correspondence and submissions.

• Drive day-to-day performance of order-to-cash systems operations and functionality. • Identify and implement process enhancements to increase efficiency, reduce errors, and improve customer and provider experience. • Partner with 3rd party software vendor and internal technical teams to support OTC systems, integrations, and enhancements. • Maintain SOPs, SLAs, and controls to ensure consistent execution and regulatory compliance (GDP, SOX, and applicable requirements). • Lead resolution of complex order issues, collaborating across teams to identify root causes and implement corrective actions. • Incorporate feedback from customers and internal stakeholders to improve workflows and user platform reliability. • Work closely with Finance, Supply Chain, Commercial, and IT teams to ensure alignment across order processing, billing, and revenue recognition activities. • Track and communicate operational performance, risks, and improvement opportunities to leadership. • Support new product launches, system updates, and process changes to ensure readiness and smooth execution. • Foster accountability and continuous improvement.

• Identifies, develops and maintains long term collaborative relationships with Key Opinion Leaders in assigned territory • Demonstrates strong communication skills with the ability to present approved scientific data of varying levels of complexity to internal and external customers • Shares appropriate approved clinical/technical information in a timely manner with the appropriate functional teams and other internal personnel • Utilizes advanced clinical and technical expertise in contacts with External Experts • Provides constructive feedback to speakers regarding accuracy and delivery of approved presentations and adherence to Compliance Policies • Fully understands and complies with Lantheus Medical Imaging Pharmacovigilance SOPs regarding Adverse Events • Identifies potential investigators for investigator sponsored trials following approved processes

• Support the execution of analytics initiatives across Technical Operations. • Identify opportunities for operational improvements, cost optimization, and performance tracking. • Develop and maintain dashboards and reporting solutions, ensuring data accuracy, usability, and alignment with business needs. • Generate actionable insights and support the creation of presentations and business cases for stakeholders. • Work with business and IT teams to extract, transform, and analyze data from multiple sources. • Participate in cross-functional projects, supporting deliverables, timelines, and coordination across teams. • Assist in the development and standardization of KPIs, metrics, and reporting frameworks.

• Identify, develop, and engage in long-term relationships with Key Opinion Leaders (KOLs) and Healthcare Providers (HCPs) in the assigned territory • Provide training to imaging/treatment centers on handling, administration, and radiation safety of current products • Educate on-site preparation and infusion processes for products, including radiopharmaceutical licensing, supporting approved imaging/therapies, and clinical trials • Educate the HCP community to ensure they have the proper knowledge and technical expertise to use Lantheus products safely and effectively. • Utilize clinical and technical expertise to institutional workflows, regional diagnostic imaging patterns, treatment guidelines, and therapeutic advances in oncology and molecular imaging. • Gather insights into the needs and interests of healthcare providers and the medical needs of patients with a focus on Lantheus approved and investigational agents. • Maintain thorough and up-to-date knowledge of imaging techniques, clinical information, and product data in the diagnostic and therapeutic radiopharmaceutical field. • Respond appropriately and document accurate scientific data in response to unsolicited questions from customers about approved and investigational products. • Support Lantheus Field Research Initiatives, including Investigator Sponsored Trials (ISTs), the Image Library, and Clinical Trials aligned with the Lantheus pipeline. • Attend national congresses and meetings, providing medical and scientific booth support as requested, in compliance with industry regulations. • Fully understand and comply with all Lantheus SOPs, working procedures, and corporate requirements.

• Designing, delivering, and continuously improving strategic and compliant learning solutions across the commercial organization. • Leading curriculum design, facilitation, assessment, onboarding, certification, and ongoing capability development for field and cross-functional teams. • Ensuring effective use of learning platforms and sales systems for continuous learning experiences that improve readiness and performance. • Collaborating with field managers, HR, and cross-functional teams to align training with business priorities. • Developing and managing curricula for disease states, product knowledge, and skills. • Facilitating various training events and creating blended learning experiences.