Position SummaryAnalytical Development (AD) supports formulation, process development, and product release for Lilly's next-generation RNA-LNP-based therapies, partnering closely with Process Development, Formulation, Bioproduct Research and Development, and other functions to ensure product quality and safety throughout the development lifecycle.
We are seeking a scientist to join the AD team within the Advanced Delivery Systems (ADS) organization in Boston, MA. Reporting to the Senior Advisor, Bioassay Development, this individual will develop, implement, and execute bioassays supporting formulation/process development, in-process monitoring and product developability studies. The successful candidate will collaborate closely with cross-functional teams and bring self-motivation, independence, and strong hands-on bench skills.
Responsibilities- Develop and implement assays to characterize LNP drug product potency, mRNA cargo, and process- and product-related impurities.
- Conduct sample testing using a variety of technical platforms (e.g., cell-based potency assays, flow cytometry, qPCR, ELISA).
- Evaluate assay performance to ensure data reliability and coherency for making critical, data-driven decisions (e.g., in-process monitoring, lot release, stability, comparability).
- Identify and troubleshoot complex analytical issues and propose effective, scientifically sound solutions.
- Work closely with cross-functional teams to ensure analytical deliverables meet project timelines and program needs.
- Analyze and interpret experimental data, present findings to stakeholders, and make clear and actionable recommendations to the project team.
- Author test protocols, qualification reports, and other technical documents.
- Develop lifecycle management of reference materials and critical reagents and equipment to meet operational requirements.
- Track and recommend innovative bioassay techniques to address challenging analytical issues based on emerging scientific insights and program needs.
Basic Qualifications- Bachelor's or Master's degree in molecular biology, biochemistry, or a related biological science, with 3-6 years of industry experience in bioassay development.
- PhD will not be considered at this job level.
- Hands-on experience with cell-based potency assays and/or other bioassays (e.g., flow cytometry, qPCR, ELISA).
- Hands-on experience in mammalian cell culture.
- 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.
Additional Skills and Preferences- Experience characterizing mRNA-LNP-based genetic medicines, drug product potency, and/or process- and product-related impurities.
- Familiarity with data analysis software (e.g., Prism, FlowJo, Excel) and laboratory information management systems (e.g., Benchling).
- Working knowledge of ICH guidelines related to analytical methods for cell and gene therapies.
- Ability to set priorities and effectively manage workflows and deliverables to meet stringent timelines.
- Excellent critical thinking and problem-solving skills.
- Proven ability to work collaboratively and deliver in a matrixed, cross-functional environment.
- Willingness to take on additional responsibilities as needed.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$72,000 - $161,700
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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