Research Advisor-Laboratory For Experimental Medicine

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Lilly's dedication to excellence never ends. Our values of integrity, excellence and respect for people are embedded in all that we do. This is evidenced by the work the Laboratory for Experimental Medicine (LEM) group does to ensure the integrity and safety of our research efforts.
The LEM group supports the development, transfer, and validation of assays for the quantification of novel biomarkers used to facilitate the development and regulatory approval of new molecular entities. In this role, the emphasis will be on the implementation of immunogenicity and related biomarker assays to support the clinical portfolio. The LEM Advisor will also provide scientific expertise and consultative support to Program and Product Teams, internal Lilly partners, third-party organizations, regulatory agencies and external partners on medical and scientific issues concerning immunogenicity and related novel biomarkers.
Are you ready to apply your outstanding background to contribute to the discovery of therapies that will impact patients globally? We are looking to add to our dynamic and diverse team of scientists. Consider applying today!
Primary Responsibilities

• 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.
• 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.
• 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.
• Stay current on new TPO technologies/capabilities as well as ongoing performance to manage enterprise risk and make recommendations for optimal study support to LEM, CLO, and the study team,
• Ensure all activities within the LEM are carried out in compliance with expectations of regulatory agencies, and all applicable laws and agreements.
• Serve as the frontline engagement with TPO partners both current and prospective and ensure that Lilly/TPO relationship matures to a steady-state,
• Responsibilities may include:
• Contribute to scientific fields of interest through writing peer-reviewed scientific articles, and engage in relevant academic collaborations.
• Lead TPO scientific oversight activities for work relating to a TPO in a GMP-like environment.
• 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.
• Accountable for data, protocols and reports provided to and received from TPOs,
• Successfully training new employees on sponsor oversight documentation and scientific skills related to LEM immunogenicity and biomarker outsourcing, especially assay transfer, validation, and sample analysis.
• Accountable for understanding and applying regulations as they relate to the analytical method transfer, validation, and execution.
• Lead in trouble-shooting scientific assay issues with the TPO,
• Remain active within the field of Immunogenicity and Biomarker analyses through literature search/reviews and providing technical leadership to LEM.
• Lead the transfer of in-house knowledge and assays (both cell-based and ligand-binding) to TPO,
• Maintain documentation for sponsor oversight activities, as outlined in LRL and LEM SOPs and policies.
• Lead TPO site visits, scientific discussions with TPO staff, and relate feedback to appropriate internal/external scientists,
• Partner with the LEM clinicians to drive formulation of comprehensive TA biomarker strategies.

Minimum Requirements
Ph.D. in scientific field or M.S. with 5 years or more of relevant experience
Additional Preferences

• Excellent experimental design skills; scientific approach to problem solving; method development, validation and sample analyses
• Excellent oral and written communication skills
• Ability to investigate new innovative clinical biomarker and immunogenicity analytical technologies
• Experience in a regulated (e.g. GLP, GCP, GMP, etc.) environment, specifically related to immunogenicity and biomarkers.
• Ability to influence and mentor other individuals
• Strong background in (screening and neutralizing) immunogenicity assays with at least 5 years of industry experience in this specialized area.
• Experience in molecular biology, analytical diagnostic techniques, cellular immunology assays, binding assays, and/or immunohistochemistry
• Proven leadership, organizational and relationship-building skills
• Familiarity with the design and conduct of clinical trails

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