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Full-Time

Manager – Gene Therapy Quality Control Critical Reagents

Confirmed live in the last 24 hours

Sarepta

Sarepta

Compensation Overview

$112k - $140kAnnually

Senior, Expert

Andover, MA, USA

Requires onsite presence at Sarepta’s facility in Andover, MA.

Category
Genomics
Biology Lab & Research
Biology & Biotech
Requirements
  • B.S. or M.S. in molecular biology, cell biology, virology or related field with at least 7+ years relevant experience in QC GMP environment in a clinical and/or commercial setting. Commercial experience is a strong plus.
  • A strong technical background and proven track record in Quality Control with methods related to cell biology, biochemistry, and molecular biology.
  • Experience managing direct reports and developing next-level leaders.
  • Experience authoring policy documents, SOPs, protocols, and reports for qualification, maintenance, and monitoring of QC critical reagents and reference standards.
  • Technical knowledge of and experience in cell-based and molecular biology-based assays (Potency assay, cell-based ELISA, qPCR, ddPCR assays).
  • Strong understanding of cGMP/ ICH/ FDA/ EU regulations.
  • Experience with and good understanding of statistical software packages such as JMP, for trending applications.
Responsibilities
  • Collaborate internally and externally (Contract Testing Labs and Contract Manufacturing Organizations) to manage lifecycle and monitoring of critical reagents and reference standards integrated inventory related to gene therapy test methods for in-process, release, and stability testing.
  • Responsible for selection of vendors, procurement, tracking and trending critical reagents and reference standard performance.
  • Support of cGMP operations, including technical review of change control documentation and reports, deviations, OOS, and other investigations.
  • Lead laboratory experiments internally for manufacturing and/ or qualification of critical reagents.
  • Lead the review of internal SOPs/ policies to align with industry standards related to analytical method and critical reagent lifecycle.
  • Lead the implementation of reference standard program for analytical methods and bioassays.
  • Provide support to the department leadership with the implementation of new systems and continuous improvement efforts.
  • Participate in the generation of new ideas to create efficiencies and improve processes.
  • Assist with regulatory and internal inspections, as needed.
  • Manage 2-3 direct reports.

Company Stage

N/A

Total Funding

N/A

Headquarters

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Founded

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