Quality Control Associate

Lilly • Boston, MA

5d

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.
Organization Overview:
Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company within Lilly Research Labs, is a clinical-stage genetic medicine 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. The company’s initial three 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. VERVE-102 is designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia.

Requirements

• BS in a scientific or related field.
• 4+ years of experience in a biotechnology or pharmaceutical company
• Strong organizational skills and attention to detail.
• Ability to collaborate and work in a cross-functional environment.
• Strong writing and communication skills.

Nice To Haves

• JMP and SLIM experience preferred.
• Proficiency in Microsoft Word and Excel.

Responsibilities

• Manage test method transfer/qualification/validation for GMP methods at contract laboratories to support Drug Substance and Drug Product in-process, release, and stability testing.
• Review and approve method qualification protocols, reports, and test methods.
• Manage the review and approval of all data related to method transfer, qualification, and validation.
• Manage qualification, implementation, and inventory monitoring of reference standards, controls, and critical reagents.
• Manage establishment of method performance trending spreadsheets and once implemented, lead continuous monitoring activities.
• Work with other functional groups (e.g., Quality Assurance, Technical Operations, Process Development and Regulatory Affairs) to author QC SOPs, protocols, and reports.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level