About The Position

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. The Analytical Development group is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials, RNA drug substances, and LNP products and programs at various development stages. Additionally, the role includes testing non-GMP samples to support development studies such as comparability assessments, process development, stability, product, and process characterization. The position is part of a Technical Operations team that partners closely with Quality Control, Quality Assurance, Process Development, and Analytical Research & Development.

Requirements

  • BS Degree in a life sciences field such as in Biology, Biochemistry, Microbiology, Molecular Biology, Virology, or related field with 4+ years of relevant industry experience OR MS Degree with 2+ years of relevant industry experience
  • Qualified applicants must be authorized to work in the United States on a full-time basis.
  • Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
  • Proven hands-on experience in qPCR/dPCR/ddPCR, RT-qPCR, ELISA, and other molecular and cell-based biology techniques and assays.
  • Experience in cell culture and cell-based potency assays.
  • Proactive, creative, ability to work effectively on cross-functional teams and positive attitude.
  • Effective oral and written communication skills.

Nice To Haves

  • Experience in assay development, qualification, validation, and implementation to support target candidate validation from Non-GxP to GMP environments is desirable but not required.
  • Familiarity with applicable ICH regulations and multi-compendial guidelines related to method validation is desirable but not required.
  • Knowledge/hands-on experience in automation and liquid handlers are desirable but not required.

Responsibilities

  • Develop, optimize, and execute analytical methods intended for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and characterization of complex raw materials.
  • Review, interpret, and present data within the analytical team and cross-functionally.
  • Provide technical oversight for troubleshooting and phase-appropriate qualification and validation of analytical assays for the analysis of gRNA, mRNA, and LNP.
  • Work in partnership with internal and/or external QC to coordinate analytical method transfer within the organization or at Contract Manufacturing Organizations (CMOs)/Contract Testing Laboratories (CTLs).
  • Author, review, and revise SOPs, technical reports.
  • Provide technical oversight to guide analytical/QC investigations, as needed.
  • Actively collaborate with internal and external process development and quality teams.

Benefits

  • company bonus (depending, in part, on company and individual performance)
  • company-sponsored 401(k)
  • pension
  • vacation benefits
  • eligibility for medical, dental, vision and prescription drug benefits
  • flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • 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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What This Job Offers

Job Type

Full-time

Career Level

Senior

Number of Employees

5,001-10,000 employees

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