Nucleus RadioPharma

Design and oversee a global GMP training and qualification framework ensuring compliance and operational readiness across multiple sites. | Minimum 10-12 years of GMP-regulated pharmaceutical or radiopharmaceutical experience, with leadership in training and quality systems, and familiarity with global regulatory standards. | Job Title: Director, Global Training Reports to: VP | Quality and Regulatory Affairs Classification: Full Time, Exempt Work Location: Remote with Travel (estimated 20-30% depending on home-base) This position is remote; however, candidates must live in the Philadelphia metro area, Minneapolis metro area or Rochester, MN POSITION SUMMARY: The Director, Global Training at Nucleus RadioPharma is a strategic leader for the design, implementation, and governance of a global, GMP-compliant training and qualification framework in a dynamic, high-growth CDMO start-up environment. This role is accountable for establishing scalable training systems from the ground up and that ensure regulatory compliance, workforce qualification, and inspection readiness across the sites. Reporting to the VP, Quality and Regulatory Affairs, this role oversees the global training program to ensure personnel are appropriately trained and qualified to perform their assigned GMP responsibilities in compliance with applicable regulatory requirements. The Director is responsible for defining role-based curricula, instructional design principles, and training governance, while partnering with Quality, Operations, and Subject Matter Experts to support effective training delivery and execution. The training program is designed to scale in alignment with Nucleus' growth trajectory. The ideal candidate is a proven leader with deep experience in designing and deploying global GMP training programs aligned with global regulatory requirements (FDA, EMA, MHRA, Health Canada, PMDA, and other international agencies). This leader will foster a culture of continuous improvement, provide leadership for multi-site training activities, and represent the Nucleus training program during inspections, audits, and client engagements. PRINCIPAL RESPONSIBILITIES: Strategic Leadership • Develop, maintain, and execute a global GMP Training Program and Qualification strategy aligned with Nucleus RadioPharma's mission, client commitments, regulatory requirements and growth objectives. • Serve as a key member of the Global Quality Team, partnering with site leadership, Operations, and executive leaders to align operational priorities with GMP training, qualification, and inspection readiness initiatives. • Champion a "patient-first" culture where quality, safety, data integrity, and regulatory compliance directly support clinical development and operational success. Cross-Functional Collaboration • Partner across GMP functions to define role-based training requirements and ensure training programs meet regulatory, operational, and stakeholder needs. • Provide guidance and coaching to GMP functions to ensure training curricula, delivery methods, and qualification requirements support a competent and compliant workforce. Team Leadership and Culture • Build and lead a high-performing global team of Training professionals. • Foster a culture of accountability, inclusion, and continuous learning, ensuring team members understand their role in GMP compliance, data integrity, and product quality. • Coach and mentor emerging leaders to support organizational growth and capability. Training and Organizational Development • Lead the cGMP Technical Training organization, establishing a robust, compliant, and scalable training framework that supports adherence to applicable cGMP and radiopharmaceutical regulatory requirements across all operational areas. • Establish targeted, role-based training and qualification programs that incorporate multiple training modalities, including instructor led training, hands on education of employees (OJT), and assessments, to verify competence beyond "read and understand" SOP acknowledgement. • Ensure the Learning Management System (LMS) functions as a centralized, validated, and auditable training management system supporting documentation, tracking, assessment and verification of training and qualification activities. • Embed data integrity and right-first-time principles into training standards and curricula, reinforcing these expectations across GMP roles and responsibilities. • Establish and maintain processes to evaluate training effectiveness through defined metrics, trend analysis, and management review and implement improvements to strengthen compliance, operational readiness, and organizational excellence. • Oversee the design and governance of new employee onboarding, qualified trainer programs, GMP refresher training, and other training programs, in collaboration with Quality and Operations. Continuous Improvement and Innovation • Lead continuous improvement initiatives to enhance training processes, reduce compliance risk, and improve training effectiveness. • Introduce innovative technologies and digital tools to modernize training development, management, and delivery of training content. • Define and monitor training KPIs related to program effectiveness, completion, and qualification, status; report metrics to leadership and ensure appropriate actions are taken to address gaps and improve performance. QUALIFICATIONS & REQUIREMENTS: • Education: Bachelor's degree in Life Sciences, Engineering, Education, Organizational Development, or a related field required; advanced degree preferred. • Experience: Minimum of 10-12 years of experience in a GMP-regulated pharmaceutical, biotechnology, or radiopharmaceutical environment, including significant experience designing, implementing, or governing GMP training and qualification programs. Prior leadership experience within Quality, Compliance, Technical Operations, or Training functions is required. • Expertise: Demonstrated knowledge of GMP training and qualification requirements and quality systems, including applicable global regulatory expectations (e.g., FDA, EMA, MHRA, Health Canada, PMDA, ICH) and regulations such as 21 CFR Parts 210, 211, and 212. Familiarity with additional standards (e.g., Annex 1, Annex 2, ISO-based systems) is preferred. • Leadership: Proven track record of leading teams in a startup, high-growth, or CDMO environment, with the ability to influence across Quality, Operations, and Technical functions. • Communication Skills: Exceptional verbal and written communication skills, with the ability to clearly convey training expectations, influence cross-functional stakeholders, and interact effectively with internal teams, regulatory agencies, and external partners. • Analytical Skills: Strong problem-solving abilities, with a data-driven approach to evaluating training effectiveness, identifying gaps, and driving continuous improvement. • Travel: Willingness to travel domestically up to 30% and internationally as required to support site readiness, inspections, and major training initiatives. KNOWLEDGE, SKILLS, AND ABILITIES: • Learning Management Systems (LMS) Expertise: Experience in developing, implementing, and maintaining a LMS in compliance with applicable regulations and standards. • Risk Management: Ability to identify, assess, and mitigate risks using industry-standard tools and methodologies. • Project Management: Skilled in managing multiple projects simultaneously, with a focus on meeting deadlines and achieving objectives. • Collaboration: Strong interpersonal skills, with the ability to work effectively in cross-functional teams and build consensus among diverse stakeholders. • Adaptability: Ability to thrive in a dynamic, fast-paced startup and CDMO environment, adapting training systems and priorities in response to evolving regulatory, operational, and business needs. • Ethical Judgment: Commitment to upholding the highest ethical standards and promoting a culture of integrity and accountability. • Work Flexibility: This role will lead a national network of sites including, but not limited to, Rochester, MN, Spring House, PA and Mesa, AZ. THE FINE PRINT: 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. Candidates must be able to successfully complete a pre-employment drug screen, background check, and applicable vision testing. Candidates applying to roles in Manufacturing, Quality Control, Microbiology (Sterility Assurance), MSAT, R&D, and Engineering may require normal near visual acuity (20/20, with or without corrective lenses) and no impairment of color vision, with or without reasonable accommodation.

Lead the MSAT function overseeing technology transfer, process validation, regulatory compliance, and lifecycle management of radiopharmaceuticals across GMP facilities and partners. | Requires 12+ years in GMP manufacturing sciences with 5+ years in sterile/radiopharmaceutical manufacturing, technical leadership experience, regulatory inspection participation, and strong knowledge of radiopharma modalities and manufacturing technologies. | • *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 , 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 , 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.