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Full-Time

Scientist I

Quality Control

Confirmed live in the last 24 hours

Sarepta

Sarepta

Compensation Overview

$96k - $120kAnnually

Entry

Andover, MA, USA

Requires onsite presence at Sarepta’s facilities in the United States.

Category
Genomics
Biology & Biotech
Requirements
  • PhD degree in molecular biology, cell biology or virology with 0 - 3 years relevant experience
  • Experience in developing, validating, optimizing and deploying cell-based assays is highly desired
  • Strong background in gene expression analysis including qRT-PCR, ddPCR, and immunoassays such as Jess capillary electrophoresis, ELISA, immunoblotting
  • Familiarity with primary mammalian cell culture, in particular myoblasts, and a deep understanding of cellular differentiation and commitment
  • Operate as a part of a team with experience supervising and/or training individuals in a laboratory environment
  • Working experience in a cGMP environment is highly desired
  • Experience in general laboratory organization, experimental design, and documentation (GDP) with adherence to cGMP is necessary
  • Effective written and verbal communication skills; attention to detail is a must
Responsibilities
  • Development and validation of cell-based assays to interrogate the potency of AAV gene therapy products
  • Perform testing of release and stability samples for early and late phase clinical and commercial lots
  • Support troubleshooting and optimization of cell and molecular assays, including assay development & validations in accordance with cGMP regulations
  • Manage activities related to cell banking and managing cell supplies at Andover or external testing sites
  • Author test methods, development reports, study protocols, and validation reports
  • Support the method development, transfer and qualification/validation activities associated with the release of viral vector products
  • Author and review quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites
  • Act as company liaison with CMO/CTL/CRO to coordinate in method development and method transfer across various CMO/CTL/CRO sites as needed
  • Conduct review of laboratory data and authorization of final reports
  • Monitor, review, and trending of stability data
  • Perform other related duties incidental to the work described
  • Training and mentoring junior associates on the execution and analysis of cell-based assays

Company Stage

N/A

Total Funding

N/A

Headquarters

N/A

Founded

N/A