Lantheus · 3 days ago
Associate Director, Quality Control
Springfield, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$152K/yr - $228K/yr
10+ years expLantheus is a leading radiopharmaceutical-focused company dedicated to improving patient outcomes through innovative science. The Associate Director, Quality Control will oversee the QC department at Lantheus’ Evergreen site, ensuring compliance, efficiency, and technical guidance in operations to deliver quality radiopharmaceutical products.
Health DiagnosticsManufacturingMedical
Responsibilities
Design, establish and maintain a standard QC operational structure with assigned roles and responsibilities that can be aligned with the needs of the organization
Oversee the creation and maintenance of a QC training matrix and program to ensure consistency in execution and retention of capability & skill
Define specific qualification standards for SMEs and the subsequent qualification processes
Manage mid-management (supervisors, managers etc) direction to ensure alignment of objectives and completion of deliverables by the department
Provide technical guidance and decisions to mid-management in order to be able to achieve the required objectives and deliverables
Design, maintain and defend the internal departmental processes to ensure compliance to cGXP requirements
Oversee and manage departmental efficiency and proficiency to enable a lean operation
Review and approve department related protocols, procedures, test methods, and studies as appropriate. Responsible to create, maintain and harmonize key business processes with internal and external stakeholders
Partner with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage
Partner with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Lantheus’ business growth
Partner with site operations to effectively deliver analytical services to meet product release timelines for future product supply. Partner with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized analytical process
Leads, motivate, mentor, and develops team members to exceed and meet company goals
Develop and maintain effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities
Lead assigned operational personnel in owning Quality processes within the required responsibility of the department (i.e. Change controls, Investigations, CAPAs, Protocol & report writing)
Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders
Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment
Report and take initiative to correct safety and environmental hazards
Actively demonstrate Lantheus’ values
Qualification
Required
Requirements include a B.S. in relevant scientific/technical disciplines, advanced degrees (e.g., MS) or technological certificates preferred but not required
Minimum 10+ years experience in a GMP Quality Control Environment
Minimum 5+ years experience in people management and conflict resolution
Minimum 3+ years experience in defending QC operations against FDA and EMEA regulatory inspections
Preferred
2+ years of experience in the radiopharmaceutical industry preferred but not required
Previous experience with managing a microbiology department is preferred
Previous experience working with sterile filled/finished drug products, medical device, radiopharmaceuticals and CDMO management strongly preferred
Subject matter expert (SME) in various analytical test methods and analytical technology. Strong knowledge of global regulatory requirements related to the design and control of these processes
Knowledge of SOPs, cGMPs, GCPs and GLPs and the ability to work and manage within a regulatory environment
Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product analytical processes
Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing & testing
Excellent organizational skills and the ability to successfully manage a multitude of technical projects
Ability to work in a fast paced, complex and changing environment
Excellent analytical, technical and experiences
Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills
Understanding of FDA and/or EMEA quality and regulatory processes. Prior experience with regulatory filings is highly desired
Experience working with external partners is highly desirable
Ability to work independently in decision-making and resolution of program obstacles and conflicts
Keen insight, independent judgment and tactful discretion are required
Ability to function autonomously, with an appreciation of detail while being cognizant of 'the big picture'
Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required
Benefits
Comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage
Life and disability benefits
Pre-tax accounts
A 401(k) with company contribution
A variety of other benefits
Generous time off package including paid vacation, holidays, sick days, and paid parental leave
Company
Lantheus
With more than 65 years of experience in delivering life-changing science, Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease.
501-1000 employees
H1B Sponsorship
Lantheus has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (5)
2022 (5)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
unknown2015-06-25IPO
Leadership Team
Robert Marshall
Chief Financial Officer and Treasurer
Jamie Spaeth
Chief People Officer
Recent News
2026-01-03
2025-12-19
Company data provided by crunchbase