Director, Internal Manufacturing

Lantheus • Springfield, NJ

2d • $172,000 - $287,000 • Onsite

About The Position

As a key member of the Evergreen Manufacturing site senior leadership team, the Director, Internal Manufacturing provides technical and operational leadership across radiopharmaceutical manufacturing (e.g., RLT, PET and isotope products). This role is accountable for robust, compliant, and reliable manufacturing performance through the end-to-end product lifecycle—from process design and tech transfer through routine commercial execution and continuous improvement—while ensuring operations remain in full cGMP compliance and aligned with all applicable Federal, State, and local laws and regulations. This Technical Leader partners closely with Quality, Engineering, Employee Health and Safety, Radiation Safety, Supply Chain, Chemistry Manufacturing and Controls/Regulatory, and external partners to deliver safe, on-time product and to advance technical capability, capacity, and operational excellence.

This position is based in New Jersey and requires a presence on-site 5 days per week, and open to applicants authorized to work for any employer within the United States.

Requirements

• Bachelor’s degree in chemistry, Chemical Engineering, Pharmaceutical Sciences, Biology, or related scientific/technical discipline (or equivalent experience); advanced degree preferred.
• 10+ years of experience in radiopharmaceutical, sterile, or biologics/pharmaceutical GMP manufacturing, including direct experience with radiochemistry/radiosynthesis operations and/or aseptic processing in a regulated environment.
• Demonstrated success applying Operational Excellence/Lean methodologies (e.g., 5S, value stream mapping, visual management, Kaizen, standard work) and structured problem solving to improve quality, throughput, and reliability.
• Working knowledge of GMP documentation systems and quality processes, including deviation management, change control, investigations, CAPA, and batch record review/release support.
• Experience supporting or leading qualification/validation activities (equipment, utilities, facilities, computerized systems) and process validation/continued process verification in a GMP environment.
• Proven ability to lead technical discussions with Quality and regulators/auditors, including inspection readiness, clear written responses, and effective presentation of manufacturing control strategies.
• Demonstrated ability to lead, coach, and influence cross-functional teams in a fast-paced, time-critical operations environment.

Nice To Haves

• Demonstrated knowledge of safety procedures for working in hazardous chemical and radiological environments, including radiation protection principles (ALARA), contamination control, and required monitoring practices.
• Strong knowledge of cGMP requirements, including aseptic behaviors and sterility assurance principles (as applicable), environmental monitoring, cleaning/sterilization practices, and qualification/validation expectations.
• Knowledge of radiochemistry and relevant analytical methods/instrumentation (e.g., HPLC, GC, radio-TLC, dose calibrators, endotoxin testing) and understanding of automated synthesis and dispensing equipment, with ability to support troubleshooting and continuous improvement.
• Detailed knowledge of applicable regulations and standards (e.g., GMP, OSHA, NRC/state radiation control, and relevant industry guidance), with demonstrated commitment to quality culture and data integrity.
• Strong interpersonal and communication skills, including the ability to translate complex technical topics for diverse audiences and to author clear, compliant technical documentation.
• Ability to support a time-sensitive, just-in-time manufacturing schedule, including flexibility for off-hours decision-making during deviations/events and occasional travel to support network activities, suppliers, or partners.

Responsibilities

• Provide day-to-day technical leadership for Evergreen Manufacturing Operations and the MSAT team, ensuring safety, quality, service, cost, and people performance is measured, analyzed, and improved to meet business objectives. Scope includes production teams, facilities, RSO/EHS, and manufacturing process support. Establish and govern key metrics (e.g., right-first-time, batch release cycle time, deviation rate, OEE, EM performance) and use leading indicators to anticipate and mitigate risks to product supply.
• Contribute to site and network strategy for radiopharmaceutical manufacturing, including capacity planning, capital investment, facility/utilities strategy, sourcing, make/buy decisions, partnering models, and development of technical capabilities required for just-in-time manufacturing and cold-chain distribution.
• Develop and maintain deep technical expertise in radiopharmaceutical manufacturing (RLT, PET and isotope products), including radioactive material handling and controls, radiochemistry/radiosynthesis, automated synthesis platforms, aseptic processing, sterile filtration/fill-finish interfaces (as applicable), in-process controls, and analytical/quality attributes. Ensure technical knowledge is translated into robust procedures, training, and standardized ways of working.
• Lead and/or sponsor capital projects and technical upgrades from concept through execution, including user requirements, design review, risk assessments, vendor management, commissioning/qualification/validation (CQV), and readiness for GMP use. Ensure changes are implemented through compliant change control and support rapid issue resolution during start-up.
• Serve as a key manufacturing technical representative during regulatory interactions and inspections (e.g., FDA, EMA and other agencies). Ensure sustained inspection readiness, effective responses to information requests, and timely completion of CAPAs. Partner with CMC/Regulatory on dossier content (as applicable) related to manufacturing, process validation, control strategies, and comparability/changes.
• Demonstrate visible, hands-on leadership and effective cross-functional influence. Implement and sustain tiered daily management, escalation pathways, and structured problem-solving to drive timely decisions and alignment. Ensure managers maintain active two-way communication and engagement programs to sustain commitment and performance.
• Champion radiation, chemical safety, and environmental compliance. Ensure proper handling, storage, and disposition of radioactive and other hazardous materials; maintain effective radiation protection practices (dosimetry, contamination control, radiometric monitoring, ALARA). Ensure training, supervision, and emergency response readiness to protect employees and the environment; promptly report, investigate, and correct hazards.
• Ensure a safe work environment for all employees, contractors, and visitors at the Evergreen site. Monitor the condition of the facilities and implement improvements where necessary to reduce safety risks. Champion behavior based safety and create a culture in which everyone’s actions in the plant preserve and protect the safety of themselves and others.
• Model company values and a culture of accountability, transparency, and continuous improvement, with an uncompromising focus on patient safety, product quality, and reliable supply.
• Attract, retain, and develop technical talent and frontline leaders through coaching, training, and succession planning. Build and maintain technical competency in radiochemistry, aseptic/GMP behaviors, deviation writing, problem solving, and data-driven decision-making.
• Own and drive robust Quality and issue management systems: lead/oversee deviations, investigations, OOS/OOT, root-cause analyses, CAPA development and effectiveness evaluation, ensuring timely closure, prevention of recurrence, and continuous improvement while protecting product supply and compliance.
• Lead manufacturing technical activities for new product introductions and tech transfers, including process characterization, control strategy implementation, PPQ support, operator training, and readiness-to-execute for clinical and commercial supply.
• Govern technical change control and validation lifecycle activities for manufacturing processes, equipment, facilities, utilities, and computerized systems, including continued process verification and periodic review of process performance and product quality.
• Advance manufacturing automation, data systems, and data integrity practices (e.g., MES/EBR, equipment integration, trending/analytics) to improve right-first-time performance, compliance, and throughput in a time-critical radiopharmaceutical environment.
• Partner with Supply Chain, QC, and external suppliers/CMOs to ensure materials and services meet technical and quality requirements (e.g., isotopes/targets, precursors, sterile components). Support supplier qualification, performance management, and resolution of quality events impacting supply.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director