Advisor - Analytical Development

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.

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

• Proven expertise in LC-MS-based protein characterization and assay development is required.

Additional Skills/Preferences:

• 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: <10%

• Position location: Boston

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

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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