- 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.Basic Qualifications
- Ph.D. in scientific field OR
- M.S. with 8 years or more of relevant experienceAdditional Preferences
- 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 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 ( ) 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. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly -
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Description
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 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 immunogenicity background to contribute to the support of the clinical portfolio? We are looking to add to our dynamic and diverse team of advisors. Consider applying todayResponsibilities:
