Praxis Precision Medicines, Inc. logo

Associate Director, Quality Operations, CMC

Praxis Precision Medicines, Inc.
Full-time
On-site
hybrid
$130,000 - $165,000 USD yearly
Operations
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Associate Director, Quality Operations, CMC

Company Name

Praxis Precision Medicines, Inc.

Job Overview

The Associate Director/Director, Quality Operations, CMC is responsible for operational activities ensuring product quality and compliance in the manufacture, testing, control, validation, and release of drug substance and product. They serve as the quality expert for Praxis' neurological disease product pipeline, making strategic quality decisions throughout the product lifecycle.

Responsibilities

  • Overseeing contract service providers
  • Reviewing strategic documents
  • Supporting stability programs
  • Leading investigations
  • Performing risk assessments
  • Participating in regulatory inspections

Requirements

  • BA/BS in Chemistry or related field
  • 8+ years in a GMP setting