Analyst II, Quality Control (Bioassay)

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 2023, Verve was named a Top Place to Work by The Boston Globe for the third consecutive year. Verve is headquartered in Boston, Massachusetts.The Position Verve is seeking an Analyst II, Quality Control to support potency and tissue culture-based testing in a GMP environment. The analyst in this position will be part of a growing team that aims to evaluate the quality of raw materials, drug substance, drug product, and support the preclinical studies of gene editing medicines.This is an onsite role and requires 5-days in our Boston office. We are considering local candidates at this time.Job Responsibilities Perform routine potency testing for release and stability of drug substance and drug product utilizing potency software and Veeva LIMS.Review and approval of cGMP analytical data from test methods including but not limited to mRNA expression, potency and NGS testing platforms.Responsible for thawing and maintaining cell lines required for testing.Produce analytical master and working cell banks.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.Support OOS, OOT, investigations, deviations, change controls and CAPAs pertaining to the QC laboratory.Maintain laboratory equipment and perform routine cleaning.Participate in internal laboratory audits.Interface with ARD, AD-CMC, Facilities, IT, QA and QS.Receive samples and materials, apply internal labels, and maintain adequate supplies for testing.Other duties as assigned.Qualifications B.S. degree in scientific discipline with 3 years of relevant experience in the pharmaceutical or biopharmaceutical industry 1 years demonstrated quality experience in GMP environment preferredExperience with cell culture requiredStrong written and verbal skillsAbility to communicate across various cross-functional teamsDemonstrated problem solving abilityExperience in GXP document reviewProficiency in Word, Excel, and other electronic Quality systemsDon’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 Statement Verve 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.#J-18808-Ljbffr