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SummaryWe are seeking a highly motivated scientist to drive the analytical development of cell and gene therapy programs at Lilly Boston Innovation Center. The ideal candidate will have hands-on experience developing and pre-qualifying a variety of molecular, cellular, and potency assays to support early-stage drug substance and drug product development. The candidate will collaborate with cardiovascular and metabolic research, genetic medicines, process and formulation development, analytical development, and other functional teams at the Lilly Boston and Indianapolis sites, contributing to the advancement of portfolio assets into clinical development within a highly collaborative environment. We look for an individual with leadership, self-motivation, independence, and hands-on bench skills.
Responsibilities:- Design, develop, and execute molecular assays (qPCR, ddPCR, NGS), cellular assays, and cell-based potency assays to characterize and quantify drug substances/products and in-process impurities, supporting formulation and process development of new drug modalities.
- Ensure phase-appropriate assays and scientific data generated both internally and externally meet quality and regulatory expectations.
- Influence and engage in analytical method development in discovery to facilitate R to D transition, ensuring assay suitability for development and technical transfer to CDMO partners.
- Drive the evaluation and development of innovative techniques to address challenging analytical issues based on emerging scientific insights, new technologies, and program needs.
- Represent the product research & development organization on project teams. Collaborate with cross-functional stakeholders on study protocols and develop aligned analytical plans to ensure timely delivery of decision-making data to support the overall project timeline.
- Collaborate with discovery research, analytical development, process development, manufacturing, and quality teams to ensure seamless integration and transition of drug development processes.
- Establish and oversee external collaborations to enhance internal capabilities and drive analytical innovation.
- Author, review and approve test protocols, SOPs, technical reports, and relevant sections of regulatory submissions. Participate in regulatory interactions as needed.
Basic Qualifications:- Ph.D. degree in Biochemistry or Molecular Biology, with 0-4 years of postdoctoral experience.
- At least 4 years of hands-on experience in molecular assays (qPCR, ddPCR, NGS) and cell-based potency assays.
Additional Skills and Preferences:- Hands-on experience with other bioassays or prior experience with nonviral or viral-based cell therapy is a plus.
- Strong critical thinking, problem-solving, and communication skills with a demonstrated ability to deliver in a matrixed environment.
- Knowledge of ICH/FDA guidelines and industry best practices related to analytical methods.
- Ability to set priorities to effectively manage workflows and deliverables.
- Ability to manage CDMOs and other external collaborations to deliver quality results within a stringent timeline.
Additional Information:Physical Demands:The physical demands of this job are consistent with a lab environment
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:This position's work environment is in a laboratory environment.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$138,000 - $202,400
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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