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Organization Overview:
We are seeking a highly motivated scientist to drive the analytical development of early-stage genetic medicine programs at Lilly Boston Innovation Center.  The ideal candidate will have hands-on experience in developing and pre-qualifying LC-MS-based assays to characterize proteins, lipids, oligonucleotides, and lipid nanoparticles (LNP).  The candidate will collaborate with other functional teams at Lilly Boston and Indianapolis sites and contribute to advancing portfolio assets into clinical development in a highly collaborative environment.  We are looking for an individual with leadership qualities, self-motivation, and independence.
 

Responsibilities:

Design, develop, and execute LC-MS-based assays to characterize and quantify proteins, lipids, and oligonucleotides in support of formulation and process development.

Ensure phase-appropriate assays and scientific data generated both internally and externally are in line with quality and regulatory expectations.Understand in-process and final product critical quality attributes to support a research to development (R to D) transition, assess product sensitivities and developability, and mitigate potential risks during scale-up.Influence and engage in analytical method development in discovery to facilitate R to D transition and ensure assay suitability for development.Evaluate and develop 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 genetic medicines discovery, analytical development, process development, manufacturing, and quality teams to ensure seamless integration and transition of drug development processes.Oversee CROs and other 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 Requirements:

Ph.D. degree in Chemistry or Biochemistry, with 0-2 years of postdoctoral experience.  At least 4 years of hands-on experience in the characterization and quantitation of proteins and/or oligonucleotides using high resolution LC-MS.

Additional Skills/Preferences:

Proven expertise in LC-MS-based protein characterization and assay development is required.Hand-on experience in qPCR, separation of large molecules, or LNP characterization 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’s 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 in a stringent timeline.Willingness to take on additional responsibilities as needed.

Additional Information:

Travel: