Advisor - Analytical Development

About the role

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. We 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.

Requirements

• 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.

Skills

• 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.

Work Environment

The physical demands of this job are consistent with a lab environment. The work environment is in a laboratory setting.

Pay

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).

Benefits

• Comprehensive benefit program including medical, dental, vision, and prescription drug benefits.
• Company-sponsored 401(k) and pension plans.
• Vacation benefits and certain time off and leave of absence benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).