Associate Director, Analytical Development & Clinical Quality Control

Disc Medicine

Watertown, Massachusetts, United States
Base: $158,000 - $193,000 usd annually; bonus/equi...
On-site
10-12 years qc management experience
Method validation and transfer expertise
Gmp and ich regulatory compliance knowledge
This role manages quality activities for biologics programs in clinical development ensuring compliance with ICH and GMP guidelines

Job Summary

  • This role manages quality activities for biologics programs in clinical development ensuring compliance with ICH and GMP guidelines.
  • The position requires extensive technical expertise in authoring and approving method validation protocols and reports from CDMOs.
  • Disc Medicine offers a dynamic hybrid work environment with flexibility to work remotely or from their Watertown, MA headquarters.

Matching Summary

This role manages quality activities for biologics programs in clinical development ensuring compliance with ICH and GMP guidelines.

Salary

Base: $158,000 - $193,000 USD annually; Bonus/Equity: Not specified; Benefits: Comprehensive benefits package included

Skills & Requirements

Must-have

  • 10-12 years QC management experience
  • Method validation and transfer expertise
  • GMP and ICH regulatory compliance knowledge
  • Specification setting for biologics
  • CDMO management and oversight

Nice-to-have

  • Root cause analysis tools proficiency
  • Veeva, LIMS, and Smartsheet experience
  • Statistical tool knowledge (GraphPad Prism)
  • Strong cross-functional leadership skills
  • Experience with OOS investigations

Key Requirements

  • B.S. degree required; M.S./Ph.D. preferred
  • 10-12 years pharmaceutical/biotech industry experience
  • Prior leadership experience in quality control functions

Work Rights

Not specified

Tailored Resume

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