Sr. Scientist, Analytical CMC

Eli Lilly and Company • Boston, MA

11d

About The Position

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. Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. Responsibilities: The Analytical Development group is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials, RNA drug substances, and LNP products and programs at various development stages. Additionally, the role includes testing non-GMP samples to support development studies such as comparability assessments, process development, stability, product, and process characterization. The position is part of a Technical Operations team that partners closely with Quality Control, Quality Assurance, Process Development, and Analytical Research & Development.

Requirements

• MS in analytical chemistry, biochemistry, biophysics or a related field with 3+ years in Biotech or Biopharmaceutical industry; or BS with 5+ years experience in gene therapy field.
• 2+ years of experience working with LC, GC and CE instruments.
• Experience in development/optimization, qualifying and transfer of methods to internal/external QC environment.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• Hands-on experience developing, qualifying and troubleshooting biophysical assays HPLC/UPLC (IP-RP, IEX, SEC), capillary electrophoresis (CE), DLS, Gas Chromatography (GC)and Plate based assays.
• Technical background on analytical methodologies gRNA, mRNA, and LNPs
• Experience in analytical method development, qualification, validation, and implementation to support target candidate validation from non-GxP to GMP environments.
• Familiarity with applicable ICH regulations and multi-compendial guidelines related to method validation.
• Experience in assay development, qualification, validation, transfer to GMP environments.
• Proactive, creative, and positive attitude.
• Effective oral and written communication skills.

Responsibilities

• Develop, optimize, qualify and execute analytical methods intended for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and characterization of complex raw materials.
• Collect, process, and analyze experimental data and information applying HPLC, UHPLC, capillary electrophoresis, LCMS, and/or other instrumental analysis techniques, ensure accurate and timely documentation in electronic laboratory notebook.
• Review, interpret, and present data within the analytical team and cross-functional.
• Author, review, and revise technical source documents to support phase-appropriate comparability.
• Provide technical oversight to guide analytical/QC investigations, as needed.
• Actively collaborate with internal and external process development and quality teams.
• Train and mentor junior team members.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees