Manager, External Quality Control Boston, Massachusetts, United States - Boston Massachusetts

Company: Verve Therapeutics
Location: Boston, Massachusetts
Posted On: 05/06/2025

Verve 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. The company's initial three programs - VERVE-101, 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-101 and VERVE-102 are 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. In 2024, Verve was named a Top Place to Work by The Boston Globe for the fourth consecutive year. Verve is headquartered in Boston, Massachusetts.The PositionVerve is seeking a Manager, External Quality Control who will report to the Associate Director, External Quality Control and be responsible for assisting with the continued implementation, and management of Quality Control activities at contract manufacturers and laboratory CROs for DNA, mRNA, gRNA, LNP and other drug components across all development stages. We are looking for a candidate with strong technical and compliance experience to support a pipeline of gene-editing products.Job Responsibilities

• Manage cGMP testing (in-process, release, stability) at CDMOs and contract laboratories.
• Manage day-to-day Quality Control Operations at External partners.
• Manage laboratory investigations, deviations, change controls, CAPAs and risk assessments.
• Manage the review and approval of Quality Control data and CoA/CoTs.
• Manage material specifications for excipients, drug substances and drug products.
• Manage the shipment of quality control samples from/to CDMOs and contract laboratories.
• Assist in coordination, oversight, and review of method validations at CDMOs and contract laboratories.
• Coordinate stability sample storage and testing per approved protocols.
• Other duties as assigned.Qualifications
  • B.S. degree in scientific discipline with 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry
    • 3+ years demonstrated quality experience in GMP environment preferred.
    • Technical experience with QC analytical techniques, such as HPLC, GC, CE, UV-VIS, ELISA, and cell-based potency assays.
    • Experience with analytical method validations.
    • Strong written and verbal skills.
    • Ability to communicate across various cross-functional teams.
    • Experience in GXP document review.
    • Strong computer skills - Word, Excel, and other electronic Quality systems.Don't check off every box in the requirements listed above? Please consider applying anyway. We want the best candidates for the job, and those candidates don't always meet 100% of the qualifications listed. At Verve, we are dedicated to building diverse and inclusive teams who embody the values we share: grit, spirit, drive, and passion. We look forward to learning more about your unique background.EEO StatementVerve Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.
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