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) Scientific Implementation Group (SIG) does to ensure the integrity of our research efforts. The SIG coordinates outsourced immunogenicity and related biomarker assays in support of clinical studies.

LEM SIG Research Scientists, in collaboration with LEM clinicians, provide strong scientific leadership, specifically judgment and interpretation skills, for the development, validation and application of clinical assays. We help to facilitate the development and regulatory approval of new molecular entities. This role provides expertise and autonomous consultative support to Program and Product Teams, Clinical Lab Services associates, Third Party Organizations (TPO)s, and regulatory agencies for LEM assets. Some of the key responsibilities include:

• Maintain regulatory compliance by updating current procedures with new pertinent regulatory expectations identified through collaborations with TPS, audit findings, and information generated from scientific and/or regulatory conferences.
• Remain active in scientific community through literature reviews and contribute to scientific field through writing peer-reviewed scientific articles, and engage in relevant academic collaborations.
• 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.
• 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.
• Evaluate or contribute to the evaluation of new technologies, techniques, software, or equipment. Work with the Reagent Development Group, develop and implement novel techniques on assessing ADAs and/or Biomarker assays.
• Engage in external scientific/regulatory conferences and committees for scientific guidance in the development of new industry expectations.
• Responsible for successfully training new employees on sponsor oversight documentation and scientific skills related to outsourcing, especially assay transfer, validation, and sample analysis.
• Maintain documentation for sponsor oversight activities, as outlined in our SOPs and policies.
• Occasional laboratory work to troubleshoot assays or improve robustness of assays
• Lead TPO scientific oversight activities for work relating to a TPO in a GMP-like environment. Responsibilities may include:
  • accountable for data, protocols and reports provided to and received from TPOs
  • lead the transfer of in-house knowledge and assays 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 manage enterprise risk and make recommendations for efficient study support to LEM, CLO, and the study team
  • lead in trouble-shooting scientific assay issues with the TPO serve as the frontline engagement with TPO partners, both current and prospective, and ensure that the relationship matures to a steady-state
• Accountable for understanding and applying regulations as they relate to the analytical method transfer, validation, and execution.

Do you have the ability to investigate new state-of-the-art clinical biomarker and immunogenicity analytical technologies? If you are driven by science and desire to make an impact on patients we’d love to have you join our team! Come be part of our Lilly family!

Minimum Requirements

• PhD in scientific field or a M.S. in scientific field with 5 years or more relevant experience
• Immunogenicity assay experience preferred

Additional Preferences

• Familiarity with the design and conduct of clinical trails
• Excellent experimental design skills; scientific approach to problem solving
• Strong background in (screening and neutralizing) immunogenicity assays with industry experience in this specialized area
• Experience with development of cell-based neutralizing (cNAb) Anti-Drug Antibody (ADA) assays
• Strong leadership, organizational, and relationship building skills with excellent oral and written communication skills
• Ability to influence and mentor other individuals
• 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.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does 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.

As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.