Advisor – Translational Radiochemistry
Eli Lilly and Company
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $108,000 - $181,500 per year
About the role
- Manage and be a technical expert in the development, scale-up and tech transfer of GMP processes and analytical methods for radiopharmaceutical manufacturing
- Support Lilly’s early-phase radiopharmaceutical programs by leading tech. transfer and post-validation development activities of GMP production processes and test methods
- Ensure activities are completed within the required budget and timelines
- Author and oversee the preparation of CMC regulatory documents required for health authority filings
- Work cross-functionally with Regulatory, Quality Assurance, CMC, CDMOs and other vendors
- Help to develop and execute overall program strategy for radiopharmaceutical drug product programs
- Provide technical support for any post-PV development or qualification activities
- Support routine production operations including on-site manufacturing support, technical data review, troubleshooting, investigations, and implementation of CAPAs
- Prepare and coordinate the execution of protocols associated with radioligands
- Monitor and evaluate project budget, tasks and risks; propose mitigation plans when required
- Prepare RFPs and lead the evaluation of proposals
Requirements
- PhD or MSc degree in radiochemistry, chemistry, chemical engineering, or a related discipline
- Minimum 8 years for PhD or 10 years for MSc of relevant industry experience in radiochemistry, radiopharmaceutical manufacturing, organic chemistry, or process chemistry
- Experience working in a pharmaceutical GMP manufacturing environment
- Strong process radiochemistry and analytical chemistry skills
- Demonstrated experience with imaging radioisotopes (F-18, Ga-68) and therapeutic radioisotopes (Lu-177, Ac-225)
- Knowledge of environmental health and radioprotection requirements are considered assets
- Proven ability to work independently with strong organization and communication skills
- Demonstrate ability to successfully prioritize projects and manage timelines in a fast-paced environment
- Functional knowledge of GMPs and applicable FDA, EMA, Health Canada, USP, ICH and PDA guidelines
Benefits
- eligibility for healthcare benefits
- flexible benefits (if applicable)
- life insurance and death benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMP processesanalytical methodsradiopharmaceutical manufacturingprocess radiochemistryanalytical chemistryimaging radioisotopestherapeutic radioisotopestechnical data reviewtroubleshootingCAPAs
Soft skills
organizationcommunicationproject prioritizationtimeline managementindependent work
Certifications
PhDMSc