Sr. Associate/Manager - Quality Control

Eli Lilly and Company • Boston, MA

1d • $71,250 - $161,700 • Onsite

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. Verve is seeking a Senior Associate, Quality Control Internal Operations to perform potency and tissue culture-based testing in a GMP environment. The senior associate in this position will be part of a team that aims to evaluate the quality of raw materials, drug substance, drug product, and support the clinical studies of gene editing medicines. This is an onsite, in-lab role and requires 4-days in our Boston office

Requirements

• Bachelors degree in chemistry, analytical chemistry, biochemistry, molecular biology, or related area
• 3 + years in the pharmaceutical or biopharmaceutical industry
• 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

• Previous experience in gene therapy product testing
• 5+ years demonstrated quality experience in GMP environment
• Experience in GxP document review
• Understanding of data integrity, ALCOA+ principles, and applicable FDA CFR
• Experience with cell culture, NGS, aseptic technique, and statistical data software.
• Strong ethical responsibility to adhere to FDA CFR and prioritize patient safety
• Past experience reviewing data in a quality control or analytical development laboratory environment.
• Knowledge of cGMP, ICH, FDA, MHRA, JP, and EU regulations is a must.
• Experience authoring SOPS, test methods and generating qualification protocols and reports.
• Demonstrated expertise in bioanalytical (in-vitro enzymatic and cell-based activity assays), physicochemical (HPLC, LC-MS, Capillary gel electrophoresis, DSC), and molecular biology (RT-qPCR, NGS, Sanger Sequencing) techniques.
• Strong written and verbal skills
• Ability to communicate effectively across various cross-functional teams
• Demonstrate problem solving ability (e.g. lab investigations)
• Proficiency in Word, Excel, and other electronic Quality systems

Responsibilities

• Perform routine potency testing for release and stability of drug substance and drug product applying potency software and Veeva LIMS
• Review and approve cGMP analytical data from test methods including, but not limited to mRNA expression, potency and NGS testing platforms
• Produce analytical master and working cell banks.
• Participate in continuous cell culture to support routine testing and qualifications.
• Participate in method transfers and qualifications including protocol and report authoring
• Perform qualification of controls, reference standards, and cell banks
• Trend the performance of QC assay reagents, controls, and system suitability criteria
• Troubleshoot methods by identifying areas of improvement and implementing changes through the change control process
• Author and revise QC SOPs and test methods
• Manage projects that involve implementation of tech transfer, qualification and documentation
• Support OOS, OOT, investigations, deviations, change controls and CAPAs pertaining to the QC laboratory.
• Maintain laboratory equipment and perform routine cleaning
• Engage in laboratory audits
• Receive samples and materials, apply internal labels, and maintain adequate supplies for testing
• Oversee lab-related projects and present information related to risk management, timelines, etc. internal company meetings
• Collaborate with the Analytical Development and QA to technical transfer analytical methods, develop qualification strategies, and ensure reference standard and critical reagents are maintained.
• Follow safety guidelines, cGMPS and other applicable regulatory requirements

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).

What This Job Offers

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