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    Senior Advisor - Radiochemistry & Radiopharmaceutical Development

    Eli Lily
    8+ years
    Not Disclosed
    Philadelphia
    10 Jan. 31, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Advisor - Radiochemistry & Radiopharmaceutical Development
    Location: Philadelphia, Pennsylvania, United States of America
    Category: Research & Development
    Job Type: Full Time, Regular
    Job ID: R-75514

    Company Overview:

    At Eli Lilly, we are committed to improving the lives of people around the world by bringing innovative medicines and treatments to those who need them. As a global healthcare leader headquartered in Indianapolis, Indiana, we engage in ground-breaking work to advance the understanding and management of diseases. Our 35,000 employees are dedicated to making a difference, working collaboratively to create life-changing medicines, and giving back to communities through philanthropic and volunteer efforts. Join us to be part of a team that truly puts people first.

    Position Overview:

    The Senior Advisor - Radiochemistry & Radiopharmaceutical Development will play a crucial role in supporting Eli Lilly's lead discovery programs by developing radiochemistry processes and radiopharmaceutical manufacturing processes. This individual will work collaboratively within the research and development team to synthesize and characterize radiolabeled compounds, develop and implement appropriate manufacturing processes, and ensure compliance with applicable regulatory guidelines. The position also involves providing technical support and training to internal and external partners.

    Key Responsibilities:

    • Radiochemistry Process Development:

      • Develop and optimize radiochemistry processes for the synthesis of radiolabeled compounds to support internal and external lead discovery programs.
      • Produce research and development radiopharmaceutical batches in accordance with cGXPs (current Good Laboratory and Manufacturing Practices).
      • Develop and implement analytical testing methods for characterizing radiopharmaceutical batches.

    • Documentation and Reporting:

      • Author laboratory notebook entries, standard operating procedures (SOPs), development reports, manuscripts, and patents.
      • Prepare technical documents for internal and external use, including regulatory submissions, and ensure compliance with applicable global guidelines.

    • Training and Technical Support:

      • Provide training to external partners (e.g., Contract Manufacturing Organizations, CMOs) on internal manufacturing processes.
      • Offer both onsite and remote technical support to external partners, ensuring that setups align with internal manufacturing requirements.

    • Regulatory Compliance and Industry Standards:

      • Maintain up-to-date knowledge of global cGMP regulations and industry standards, including FDA, EMA, Health Canada, USP, ICH, and PDA guidelines.
      • Ensure all activities are in compliance with regulatory and safety standards.

    • Collaborative Research:

      • Collaborate with cross-functional teams to support ongoing research initiatives.
      • Contribute to team goals and support new research efforts in the development of radiopharmaceuticals.

    • Other Duties:

      • Perform additional responsibilities as assigned, contributing to the broader goals of the research and development team.

    Minimum Qualifications:

    • Educational Requirements:
      • Master’s degree in chemistry or a related scientific field with at least 8 years of experience in research and/or development.
      • Alternatively, a Ph.D. in chemistry or a related field.

    Additional Skills/Preferences:

    • Technical Skills:

      • Working knowledge of HPLC and related analytical techniques (LC/MS, NMR) is required.
      • Experience with radiosynthesizers is preferred.
      • Familiarity with disruptive technologies such as automation, 3D printing, robotics, and AI/ML is a plus.
      • Basic knowledge of databases, programming, and software development is advantageous.

    • Regulatory Knowledge:

      • Functional knowledge of GMPs and relevant regulatory guidelines (FDA, EMA, Health Canada, USP, ICH, PDA).

    • Physical Requirements:

      • Ability to repeatedly lift and move radioactive material shielding weighing up to 50 pounds.

    • Soft Skills:

      • Strong analytical and problem-solving abilities.
      • Excellent organizational skills, with the ability to manage multiple priorities effectively.
      • Proven ability to work independently and collaboratively in a team environment.
      • Exceptional written and verbal communication skills.
      • A track record of exploring and implementing innovative solutions.

    Additional Information:

    • Travel Requirements:

      • Occasional domestic and international travel (approximately 10-20%).

    • Safety Equipment:

      • The role requires wearing Personal Protective Equipment (PPE), including steel-toed safety shoes, while handling radioactive materials.

    Benefits:

    Eli Lilly offers a comprehensive benefits package, including eligibility for a company-sponsored 401(k), pension, medical, dental, vision, and prescription drug benefits, flexible spending accounts, life insurance, wellness programs, and more.

    EEO Statement:

    Lilly is an Equal Employment Opportunity/Affirmative Action Employer. We do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

    How to Apply:

    If you need accommodations to submit a resume for this position, please complete the accommodation request form on our careers page. For more information on #WeAreLilly and our commitment to diversity and inclusion, visit our website.

    This position provides an excellent opportunity for an experienced radiochemist to contribute to the innovative development of radiopharmaceuticals in a collaborative, high-impact role at Eli Lilly.

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