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Sr. Advisor - Analytical Development

Employer
Eli Lilly and Company
Location
Boston, Massachusetts
Start date
Jan 26, 2024

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Job Details

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.

Sigilon Therapeutics, a wholly owned subsidiary of Eli Lilly and Company, is developing an implanted cellular product composed of an active cell component encapsulated within alginate hydrogel spheres for the treatment of type 1 diabetes.  We seek a Senior Advisor to join the analytical development team in Cambridge, MA to advance our cell therapy program.  The individual, reporting to the Head of Analytical Development, will lead the method development and qualification of (cell-based) potency and other bioassays in house and support technical transfer to and sample testing at CDMO.  The successful candidate will collaborate with other functional teams in Lilly Cambridge and Indianapolis sites and contribute to a variety of assay activities in a highly collaborative environment.  We look for an individual with leadership, self-motivation, and independence.  Potency assay experience supporting cell and gene therapies is a plus.


Responsibilities:

  • Collaborate with Research and Process Development to lead potency assay development and qualification, utilizing a wide range of technical platforms such as cell-based assays, ligand-binding, and flow cytometry. Provide sample testing support for process development.

  • Provide scientific justifications for release specifications to support drug substance and drug product release.

  • Represent line function on CMC and other project teams. Collaborate with cross-functional stakeholders on study protocols and develop aligned analytical plans. Ensure timely delivery of decision-making data to support CMC timeline.

  • Ensure scientific data generated internally and externally are in line with quality and regulatory expectations.

  • Provide technical oversight for assay-related activities at CDMO (technical transfer, assay qualification, quality control, troubleshooting, data/report review, etc.).

  • Author, review and approve test protocols, qualification reports, and other documents.

  • Author and review relevant sections of regulatory submissions.  Participate in regulatory interactions if needed.

  • Drive innovative approaches to address challenging analytical issues based on emerging scientific insights, new technologies and program needs.


Basic Qualifications:

  • Ph.D. degree in biochemistry or other biology disciplines with 3+ years of relevant industry experience.

  • Experience with cell-based assays for cell/gene therapies.

  • Bioassay qualification experience.

Additional Skills and Preferences

  • Minimum 2 years of experience leading projects and teams.

  • Hand-on experience in the development and qualification of bioassays in compliance with ICH guidelines for quality control and product release.

  • Ability to set priorities to effectively manage workflows and deliverables.

  • Working knowledge of cGMP.

  • In-depth knowledge of ICH/FDA guidelines and industry’s best practices related to analytical methods. 

  • Experience authoring relevant sections of regulatory submissions and responding to agency’s inquiries.

  • Demonstrated ability to manage CDMO to deliver quality results in a stringent timeline.

  • Excellent critical thinking, problem-solving and communication skills with demonstrated ability to deliver in a matrixed environment.

  • Willing to take on additional responsibilities as needed.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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