Lantheus · 1 day ago
Associate Director, MSAT
Springfield, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$152K/yr - $228K/yr
5+ years expLantheus is a leading radiopharmaceutical-focused company dedicated to improving patient outcomes through innovative science. The Associate Director, MSAT will lead the Manufacturing Science and Technology team, ensuring the design, development, and transfer of robust manufacturing processes for injectable pharmaceutical products.
Health DiagnosticsManufacturingMedical
Responsibilities
Leads technology development and transfer projects for key lifecycle injectable radiopharmaceutical products, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities
Leads a team of engineers/scientists to execute the development, characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms
Leads a team of engineers/scientists to Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies (PCS)
Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental or authoring plans or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes with internal and external stakeholders
Partners 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
Partners with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for business growth
Partners with site operations to provide a parenteral manufacturing process that is sustainable for future product supply. Partners with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized manufacturing process
Leads, motivates, mentors, and develops team members to exceed and meet company goals
Develops and maintains effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities
Leads a team of engineers/scientists to own QEs (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
Requires approximately ~20% travel
Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment
Reports and takes initiative to correct safety and environmental hazards
Actively demonstrates company values
Qualification
Required
B.S. or M.S. in relevant scientific/technical disciplines, advanced degrees (e.g., PhD) or technological certificates preferred but not required
5+ years of experience in the radiopharmaceutical industry, including 3+ years focused on technology development and tech transfer activities
If no prior radiopharmaceutical experience, 10+ years of work experience within pharmaceutical or medical device industry, 5+ years of technology development and transfer experience, within a matrixed pharmaceutical, medical device, or biotechnology organization
Previous experience working with aseptically filled/finished drug products, medical device, radiopharmaceuticals and CDMO management strongly preferred
Ability to work independently in decision-making and resolution of program obstacles and conflicts
Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required
Preferred
Subject matter expert (SME) in parenteral operations: aseptic processing, sterilization, sterile filtration, isolator technology operations. Strong knowledge of global regulatory requirements related to the design and control of these processes
Knowledge of SOPs, cGMPs 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 manufacturing processes
Ability to work within and lead different technical teams
Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing
Excellent organizational skills and the ability to successfully manage a multitude of technical projects
Ability to work in a prompt, 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 EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired
Experience working with external partners is highly desirable
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'
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