Associate Director - Quality Control

Eli Lilly and Company • Boston, MA

1d • Hybrid

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, based in Boston, Massachusetts, is a clinical-stage company. The company focuses on developing one-time gene editing medicines for cardiovascular disease. Founded by leaders in cardiovascular medicine, human genetics, and gene editing, Verve aims to replace treatment paradigms from chronic diseases management to novel ‘once and done’ single-course gene editing therapeutics. The company’s advanced development programs – VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. This is hybrid position, 3 days onsite / 2 days remote

Requirements

• Bachelor's degree in a scientific or related field
• 9+ years of experience in Quality Control in the pharmaceutical industry

Nice To Haves

• Experience working with CDMO labs and other external contract test labs including method transfer, qualification/validation, release testing, stability testing
• Strong understanding of GMP specifically in the pharmaceutical industry
• Experience with mRNA and/or LNP analytical methods
• Knowledgeable in cGMP including phase appropriate method qualification, stability, laboratory investigations, and risk assessment from a technical and regulatory compliance perspective.

Responsibilities

• Reporting to the Senior Director, Quality Control, the Associate Director, Quality Control External Operations will be responsible for leading analytical testing at contract manufacturers and CROs for LNPs and other materials.
• Manage GMP Drug Substance and Drug Product testing (in-process, release, stability) at CDMOs and contract laboratories
• Responsible for end-to-end QC batch release
• Manage Laboratories investigations, deviations, change control, CAPAs and Risk assessment.
• Manage the review and approval of Quality Control data and CoA/CoTs
• Manage material specifications and change controls for LNP Drug Products
• Manage the shipment of quality control samples from/to CDMOs and contract laboratories.
• Coordinate stability of sample storage and testing per approved protocols.
• Work with other functional groups (e.g., Analytical Development, Quality Assurance, Technical Operations, Process Development and Regulatory Affairs) to author QC SOPs, Protocols, and Reports
• Work with Regulatory for authoring/coordinating and updating clinical filings and responding to agency questions.
• Participate in external audits and ensure timely closure of audit findings.

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: Director