Senior Applied Scientist developing optimizing and ML models for inventory management at MaintainX. Shaping decision processes and interacting closely with product and design teams.
About the role
- Principal Scientist leading analytical method development and validation for clinical-stage radiopharmaceuticals at Lilly. Ensuring compliance with industry standards and managing laboratory studies efficiently.
Responsibilities
- Carry out analytical laboratory studies with radiopharmaceuticals, including method development, validation, and sample analysis, for bulk material, vials, peptides, or peptide–radioactive conjugates, ensuring strict adherence to cGLP and cGMP requirements.
- Develop, author, and maintain analytical test methods, method validation protocols and reports, following USP, EP, and ICH guidelines.
- Execute method validation and feasibility studies with precision, accuracy, and reproducibility, maintaining high-quality records of all experimental work.
- Review and interpret experimental data generated internally and by external vendors/partners; summarize results in comprehensive, clear, and regulatory-compliant documentation.
- Lead technology transfer of analytical methods to external CDMOs, ensuring all procedures, instructions, and reports are complete, accurate, and compliant.
- Partner with Quality teams to review manufacturing and analytical data, conduct trending, and ensure compliance with internal and regulatory standards.
- Maintain a safe laboratory environment, strictly following radiation safety protocols, SOPs, and best practices for working with isotopes.
- Promote safety awareness among all team members.
Requirements
- Bachelor's degree in chemistry, analytical chemistry or a related discipline, with 3+ years of relevant industry experience in analytical development, method validation, and/or testing within a GMP-regulated environment.
- Strong hands-on experience with modern analytical techniques, including TLC, HPLC/UPLC, GC, NMR, and mass spectrometry.
- Strong knowledge of GMPs and applicable FDA, EMA, Health Canada, USP, ICH, and PDA guidelines.
- Demonstrated ability to work independently with strong organizational, communication, and collaboration skills in a matrix environment.
Benefits
- eligibility to participate in a pension plan
- vacation benefits
- eligibility for healthcare benefits
- flexible benefits (if applicable) life insurance and death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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