Nucleus RadioPharma

Compensation

Full Description

• *This position will be remote until the Ambler, PA site is operational. This role will require up to 50% travel to our Rochester, MN site** Position Summary The Director/Senior Director of MSAT oversees the full industrialization, technology transfer, and lifecycle management of theragnostic radiopharmaceuticals across GMP facilities and external partners. This leader ensures smooth product launches, robust process controls, operational agility and efficiency, and inspection-ready compliance, while fostering innovation, training, and continuous improvement. In partnership with cross-functional teams, this role helps establish both clinical and commercial radiopharma sites, serving as the critical link between R&D and Operations to embed quality by design from concept through commercialization. The Director/Senior Director also leads a highly skilled technical team responsible for all technology transfers, driving a unified site strategy that ensures a reliable supply of medicines to patients. Key Responsibilities • Define and execute the MSAT strategy for clinical and commercial radiopharmaceuticals, fully aligned with end-to-end Operations. • Partner on the design and build of manufacturing sites to meet long-term network and business objectives. • Lead cross-functional collaboration with R&D, Quality, Safety, Supply Chain, and CDMOs to enable seamless technology transfer and lifecycle management. • Build and mentor a high-performing technical team, fostering operational excellence, safety, and compliance. • Direct all internal and external technology transfers, ensuring harmonized processes, documentation, and knowledge flow for predictable operations. • Translate R&D insights into robust, phase-appropriate manufacturing strategies and oversee production scale-up to commercial sites under FDA/EMA regulations. • Drive process validation (PPQ) and clinical/commercial readiness, supporting continuous process validation (CPV) and lifecycle optimization with proactive monitoring and preventive controls. • Oversee aseptic operations and contamination-control strategies in line with EU Annex 1 and FDA guidance. • Manage end-to-end process validation, improvements, and eventual decommissioning. • Ensure compliance with global regulations (21 CFR 210/211/212, USP <825>, EU GMP Annex 1/3, NRC, DOT Class 7). • Serve as SME during inspections and regulatory interactions. • Select, commission, and validate radiosynthesis platforms, hot cells, and automation systems; support training on new technologies. • Oversee transfer documentation (URS, pRA, PQ) and deploy MES/eBR, LIMS, and quality-by-design solutions for data integrity and review-by-exception. • Implement digital analytics to increase transparency and manufacturing efficiency. • Develop dual-source isotope supply strategies (e.g., Lu-177, Ac-225) and ensure vendor qualification. • Oversee cold-chain logistics and DOT-compliant radiopharmaceutical transport. • Partner with Supply Chain to secure consumables, spare parts, and critical materials. • Collaborate with QA on investigations, CAPA, deviations, and root-cause analysis. • Apply ICH Q9 risk management to proactively address compliance and operational challenges. • Drive continuous improvement to stabilize processes, enhance yield, and reduce cost without compromising safety or quality. • Develop and deliver training programs, including OJT/OJQ for specialized radiopharma operations. • Ensure radiation safety and ALARA compliance in partnership with RSO and EHS. • Cultivate a culture of technical excellence and regulatory compliance across the MSAT/Technology Transfer function. QUALIFICATIONS & REQUIREMENTS • Degree in Chemical Engineering, Radiochemistry, Pharmaceutical Sciences, Medical Physics, or related field. • 12+ years of GMP manufacturing sciences experience with at least 5 years in sterile manufacturing or radiopharmaceuticals. • Demonstrated success leading technology transfer, process validation, and regulatory inspections. • Strong knowledge of radiopharma modalities including RLT, PET, and SPECT. • Strong collaboration and teamwork – working with various teams to ensure seamless and compliant processes from discovery to finished product • Experience implementing MES/eBR and digital manufacturing solutions. • Regulatory expertise across USP <825>, 21 CFR 210/211/212, EU Annex 1 & 3, NRC, and DOT requirements. • Leadership experience within a global MSAT or technical operations leader • Experience in aseptic processing and techniques required. • Direct participation in FDA or EMA regulatory interactions and pre-approval inspections is required • Product / Process Development & Manufacturing experience in Biologics, Radiopharmaceutical development, formulation, and production is preferred • Experience designing and writing documentation on hot cell functionality required. • Experience with industry standard automated synthesis units, dispensing units, and packaging automation required. • Strong mechanical aptitude and scientific background is required of mfg processes, change control • Must be capable of providing front line troubleshooting of manufacturing equipment and process issues and can properly elevate concerns and issues to appropriate personnel • Superior teamwork, multi-tasking, and time management skills. • Excellent communications, interpersonal and collaboration skills, and ability to interact professionally with a wide range of individuals and organizations, both internal and external. • Ability to work independently with minimal direction, and drive deliverables through to completion by deadlines provided by Nucleus or sponsor. • Highly organized with strong attention to detail and commitment to high quality work. • Ability to work in a collaborative manner; identify challenges and barriers and recommend resolutions. • Excellent communication, analytical, problem solving, presentation and computer/pc skills including Microsoft Suite and related software. • Ability to travel up to 50%. • Must be able to visually discern, distinguish, inspect, assess, and observe quality of product daily. • Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift 20 lbs. and to handle frequent crawling, stooping, crouching, and kneeling. • May be subject to respiratory fit tests to ensure job and environmental safety. • Preferred: Proven isotope supply strategy development for Lu-177 and Ac-225 THE FINE PRINT: The salary range for this position is $175,000 - $225,000 per year. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, experience, and location. Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation is available to qualified team members. This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”. Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.