Research Advisor-Laboratory for Experimental Medicine
Eli Lilly
- Indianapolis, IN
- Permanent
- Full-time
- Ensure LEM compliance with company policies, including confidentiality agreements, contract compliance, invention disclosure memos, laboratory notebooks, material transfers, sharing of scientific information, self-inspection, quality and documentation procedures.
- Ensure all activities within the LEM are carried out in compliance with expectations of regulatory agencies, and all applicable laws and agreements.
- Lead TPO scientific oversight activities for work relating to a TPO in a GMP-like environment.
- Accountable for data, protocols and reports provided to and received from TPOs.
- Lead the transfer of in-house knowledge and assays (both cell-based and ligand-binding) to TPO.
- Lead TPO site visits, scientific discussions with TPO staff, and relate feedback to appropriate internal/external scientists.
- Stay current on new TPO technologies/capabilities as well as ongoing performance to handle enterprise risk and make recommendations for optimal study support to LEM, CLO, and the study team.
- Lead the trouble-shooting efforts regarding scientific assay issues with the TPO.
- Serve as the frontline engagement with TPO partners both current and prospective and ensure that Lilly/TPO relationship matures to a steady-state.
- Be accountable for understanding and applying regulations as they relate to the analytical method transfer, validation, and execution.
- Remain active within the field of Immunogenicity and Biomarker analyses through literature search/reviews and providing technical leadership to LEM.
- In collaboration with the Reagent Development Group, develop and implement novel techniques on assessing ADAs and/or Biomarker assays. Evaluate or contribute to evaluation of new technologies, techniques, software, or equipment.
- Engage in external scientific/regulatory conferences and committees for scientific guidance in the development of new industry expectations. Maintain current regulatory compliance by leading the revision of current procedures with new pertinent regulatory expectations identified through discussions with partners, documented audit findings, and information generated from scientific and/or regulatory conferences.
- Contribute to scientific fields of interest through writing peer-reviewed scientific articles, and engage in relevant academic collaborations.
- Successfully train new employees on sponsor oversight documentation and scientific skills related to LEM immunogenicity and biomarker outsourcing, especially assay transfer, validation, and sample analysis.
- Maintain documentation for sponsor oversight activities, as outlined in LRL and LEM SOPs and policies.
- Partner with the LEM clinicians to drive formulation of comprehensive TA biomarker strategies.
- Build technical and process core proficiency in enabling technologies relating to ligand binding, immunoassays, immunogenicity assays, reagent generation (recombinant proteins and monoclonal antibodies), and mass spectrometry assays.
- Ph.D. in scientific field OR
- M.S. with 8 years or more of relevant experience
- Strong background in (screening and neutralizing) immunogenicity assays
- Excellent experimental design skills; scientific approach to problem solving; method development, validation and sample analyses
- Experience in molecular biology, analytical diagnostic techniques, cellular immunology assays, binding assays, and/or immunohistochemistry
- Experience in a regulated (e.g. GLP, GCP, GMP, etc.) environment, specifically related to immunogenicity and biomarkers.
- Ability to investigate new innovative clinical biomarker and immunogenicity analytical technologies
- Familiarity with the design and conduct of clinical trails
- Proven leadership, organizational and relationship-building skills
- Excellent oral and written communication skills
- Ability to influence and mentor other individuals