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
We are seeking an Associate Director, Technical & CMC Support (PET Quality
Operations) to provide strategic and operational Quality oversight for
Chemistry, Manufacturing, and Controls (CMC) activities across the PET portfolio
and external manufacturing network. This role supports regulatory submissions,
technical transfers and site activation, product lifecycle management, supplier
and CMO oversight, and continued compliance with applicable current Good
Manufacturing Practice (cGMP) and regulatory requirements.
The Associate Director, Technical & CMC Support will serve as a key
cross-functional partner to Technical Operations, Regulatory Affairs,
Manufacturing, Supply Chain, and external manufacturing partners. The successful
candidate will apply strong technical judgment and Quality leadership to resolve
complex issues, maintain product and process integrity, support reliable supply,
and advance continuous improvement.
This is a remote position open to applicants authorized to work for any employer
within the United States. Travel to Lantheus and external partner sites is
required, as business needs dictate.
Responsibilities
Lead and support CMC Quality activities, including authoring, review, and
approval of Module 3 content, technical reports, regulatory submissions,
responses, and supporting documentation.
Provide Quality oversight for commercial product lifecycle management,
including post-approval changes, stability programs, specifications,
regulatory commitments, and associated governance forums.
Provide QA oversight for technical transfers from development through
commercial readiness, including analytical and process transfer
documentation, qualification activities, readiness assessments, and site
activation.
Partner with internal stakeholders and external contract manufacturing
organizations (CMOs) to ensure technical documentation, manufacturing
controls, and Quality systems remain aligned with regulatory expectations and
Lantheus standards.
Oversee Quality performance of external manufacturing partners through
risk-based monitoring, review of key performance indicators and trends, audit
support, due diligence, and continuous improvement activities.
Support and approve deviations, investigations, change controls, corrective
and preventive actions (CAPAs), qualification documentation, site procedures,
and batch-related documentation, as assigned.
Evaluate environmental monitoring data, sterility assurance programs, aseptic
process simulation outcomes, and microbiological or process performance
trends to identify risk and drive appropriate action.
Provide technical Quality support for batch record review, sterility
reconciliation, and product disposition activities to ensure decisions are
compliant and scientifically justified.
Lead or contribute to cross-functional governance and decision-making for
changes, specifications, stability, site readiness, product supply, and other
technical or compliance matters.
Lead and participate in internal and external audits and regulatory
inspection readiness activities, including preparation, execution, response
development, and follow-up commitments.
Support responses to regulatory authority questions and inspections and help
ensure inspection readiness across supported products, sites, and activities.
Identify emerging technical, regulatory, and compliance risks; communicate
clear assessments and recommendations to stakeholders and senior leadership.
Mentor colleagues and promote consistent, risk-based Quality decision-making,
knowledge sharing, and continuous improvement across the organization.
Basic Qualifications
Bachelor’s degree in chemistry, pharmaceutical sciences, engineering, life
sciences, or a related scientific discipline.
Minimum of 10 years of progressive experience in pharmaceutical Quality,
manufacturing, technical operations, CMC, or a related function.
Demonstrated experience supporting sterile or aseptic manufacturing and
associated Quality systems.
Strong working knowledge of cGMP requirements and CMC regulatory expectations
applicable to pharmaceutical manufacturing.
Experience with technical transfer, product lifecycle management, deviations,
change controls, CAPAs, and inspection or audit readiness.
Excellent written, verbal, and presentation skills, with the ability to
communicate complex technical and Quality matters clearly to stakeholders at
all levels.
Demonstrated ability to lead through influence, manage competing priorities,
and work effectively across internal functions and external organizations.
Ability and willingness to travel to company and external partner locations,
as required.
Preferred Qualifications
Advanced degree in a scientific, engineering, pharmaceutical, or related
discipline.
Experience with positron emission tomography (PET), radiopharmaceutical
manufacturing, or other short-shelf-life sterile products.
Experience with CMC regulatory submissions, including review or authoring of
Module 3 content and post-approval change documentation.
Experience overseeing CMOs, suppliers, or external manufacturing networks,
including audits, due diligence, metrics, and Quality improvement plans.
Strong technical understanding of aseptic processing, environmental
monitoring, sterility assurance, analytical methods, process validation, and
manufacturing facility requirements.
Knowledge of FDA, ICH, and other relevant global regulatory requirements and
guidance.
Lean or Six Sigma certification or demonstrated experience applying
structured continuous improvement methods.
Proficiency with Microsoft Office applications and electronic Quality
management systems.
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 $139,000 and $232,000 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. 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. Interested candidates can apply at Lantheus.com. Applications for this
position will be accepted until November 19, 2026.
Lantheus is committed to equal employment opportunity and non-discrimination for
all employees and qualified applicants without regard to a person's actual or
perceived race, color, creed, religion, national origin, ancestry, citizenship
status, age, sex or gender (including pregnancy, childbirth, related medical
conditions and lactation), gender identity or gender expression, sexual
orientation, marital status, military service and veteran status, disability,
protected medical condition as defined by applicable state or local law, genetic
information, or any characteristic protected under applicable federal, state, or
local laws and ordinances.
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 [talentacquisition@lantheus.com].
Lantheus is an E-Verify Employer.
Applicants have rights under Federal Employment Law: Employee Polygraph
Protection Act (EPPA)
[https://www.dol.gov/agencies/whd/posters/employee-polygraph-protection-act]; Family
and Medical Leave Act (FMLA) [https://www.dol.gov/agencies/whd/posters/fmla]
For California Applicants: Family Care & Medical Leave & Pregnancy Disability
Leave; [https://calcivilrights.ca.gov/posters/?openTab=1] California Law
Prohibits Workplace Discrimination & Harassment;
[https://calcivilrights.ca.gov/posters/?openTab=1] Your Rights and Obligations
as a Pregnancy Employee [https://calcivilrights.ca.gov/posters/?openTab=1]
For Ohio Applicants: Know Your Rights: Equal Employment Opportunity is the Law
[https://civ.ohio.gov/decisions-and-publications/informational-brochures/1-know-your-rights]