Summary of RoleWe 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 ValuesThe 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.
