Summary of roleThe Associate Director, Manufacturing Science & Technology (MSAT) provides technical and people leadership for MSAT activities supporting pharmaceutical and/or radiopharmaceutical drug product manufacturing across internal manufacturing operations and external contract manufacturing organizations. This role is accountable for the design, development, transfer, and lifecycle support of robust manufacturing processes to ensure reliable, compliant product supply.
The Associate Director, MSAT serves as a principal technical expert and process owner for assigned products and manufacturing networks, leading cross-functional teams to execute technology transfer, process validation, investigations, and continuous improvement initiatives in alignment with cGMP requirements, internal quality systems, and regulatory filings.
This position is based in
New Jersey and requires a presence
on-site 4 (Four) days per week, and open to applicants authorized to work for any employer within the United States.
Responsibilities- Act as MSAT technical lead and process owner for assigned products and manufacturing networks across internal sites and external manufacturing partners.
- Lead and oversee technology development and technology transfer activities from early implementation through clinical and commercial manufacturing, including process characterization, equipment qualification, validation, and manufacturing readiness.
- Provide technical and strategic oversight to ensure manufacturing processes are designed, validated, and maintained in compliance with applicable cGMPs, internal procedures, and regulatory commitments.
- Lead and manage MSAT staff, including assignment of work, prioritization of activities, mentoring, and technical development of team members.
- Oversee and approve deviation investigations, root cause analyses, CAPAs, and change controls related to manufacturing processes, equipment, materials, or sites.
- Review, approve, and co-author key technical documentation including technology transfer packages, validation strategies, protocols, reports, and regulatory support documents (CMC-related).
- Partner with Manufacturing, Quality, Validation, Engineering, Supply Chain, and external partners to resolve complex technical issues and support uninterrupted product supply.
- Provide hands-on technical leadership and decision-making support during manufacturing startup, tech transfer execution, and significant process changes.
- Establish and maintain effective working relationships with CDMO leadership and site teams; serve as a senior MSAT interface for external manufacturing partners.
- Support regulatory inspections, audits, and health authority interactions as a technical subject matter expert, including preparation and review of responses.
- Contribute to the development, harmonization, and continuous improvement of MSAT business processes, standards, and SOPs across the manufacturing network.
- Actively promote safety rules and awareness, demonstrating good safety practices at all times and taking initiative to correct safety and environmental hazards.
- Actively demonstrate Lantheus values and leadership behaviors in all interactions.
Basic Qualifications- Bachelor's degree in engineering, Chemistry, Pharmaceutical Sciences, or a related scientific discipline with 8+ years of relevant industry experience; or master's degree with 6+ years of relevant experience; or PhD with 4+ years of relevant experience.
- Demonstrated experience leading technology transfer and manufacturing support activities in a cGMP-regulated pharmaceutical or radiopharmaceutical environment.
- Prior experience supporting both internal manufacturing operations and external CMOs/CDMOs.
- Strong working knowledge of pharmaceutical manufacturing processes, quality systems, and regulatory expectations.
- Proven experience leading and developing technical teams.
Preferred Qualifications- Subject matter expertise in parenteral and/or sterile drug product manufacturing, including aseptic processing, sterile filtration, isolator technologies, and process control strategies.
- Demonstrated ability to lead complex, cross-functional technical initiatives in a matrixed organization.
- Strong organizational, analytical, and problem-solving skills with the ability to manage multiple priorities.
- Strong verbal and written communication skills, including the ability to communicate complex technical topics to diverse audiences.
- Willingness to work onsite as required to support manufacturing operations.
- Ability to travel domestically and internationally (approximately up to 20%) to support internal sites and external manufacturing partners.
- Ability to function autonomously with sound judgment, attention to detail, and appreciation of the broader business and regulatory context.
The pay range for this position is between $139,000 and $232,0000 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. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until July 7, 2026.