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This role provides technical support and training for radiopharmaceutical preparation as well as participating in validation activities, CDMO (Contract Development/Manufacturing Organization) qualification initiatives, technical transfers, troubleshooting, and continuous improvement endeavors.  Role will provide leadership and technical expertise - both internally and externally - to cross-functional teams as well as support field execution with focus on compliance with industry regulations, quality standards, and regulatory frameworks.  This role also provides first line technical support for ongoing batch manufacturing.

Key Accountabilities:

• Technical lead of tech transfer and manufacturing activities related to drug substance and drug product formulation, radiolabeling, and fill/finish of small molecule and biologic based radiopharmaceuticals
• Analyze production processes and report results. Identify and communicate gaps, risks, and inefficiencies. Drive implementation of process improvements and risk mitigations. Lead manufacturing investigations and root cause analyses
• Support implementation of cold and hot analytical methods under the guidance of internal QC SMEs, ensuring alignment with approved methods, validation requirements, and quality standard.
• Provide support to Regulatory Affairs for product IND and new NDA submissions, support inspection readiness, participate in regulatory agency inspections, and provide audit support, as required
• Manage technical collaborations with multiple CDMOs to provide technical support and achieve key project milestones
• Author and review documents such as SOPs, batch records, protocols, and reports to produce clinical and/or commercial products
• Ensure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system
• Follows procedures to support intellectual property protection
• Provide first line technical support for ongoing batch manufacturing as the first point of contact for technical questions, concerns, and/or escalations
• Work closely and collaboratively with Quality Assurance to provide ongoing support to manufacturing partners

Education and Experience:

• Bachelor's or Master's degree in science or engineering with > 7 years of experience in the radiopharmaceutical industry, including GMP; or PhD in science or engineering with >5 years of experience in radio-pharmaceutical or biopharmaceutical industry, including GMP. PET manufacturing, handling of automated synthesis modules, and analytical experience is desirable
• Handson experience with multiple isotopes like F-18, Lu-177 and I-131 etc. are a plus for this position
• Demonstrated leadership and managerial skills
• Experience working cross-functionally with a team of internal scientists and engineers, managing external CDMOs to ensure compliance with project timelines/cGMPs, and on-going manufacturing operations
• Experience working in radiopharmaceutical manufacturing environments, including knowledge of radiation safety principles, ALARA, and applicable regulatory requirement
• Experience in MS Office suite applications (e.g., Excel, Word, Project)
• Experience in authoring challenging technical documents, including but not limited to, protocols, reports, SOPs, and quality investigations
• Experience in radiopharmaceutical and process development

Key Capabilities:

• Autonomy: Comfortable working independently with senior-level support
• Strong communication skills: Able to communicate effectively with internal and external colleagues and stakeholders, using clear and concise language.
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

Travel expectation: ~10-25% (including international, overnight, and weekend) may be required for key in-person meetings, partner site visits, and SME/technical assignments