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QC Manager

  • Job type: Permanent
  • Location: Cambridge, Massachusetts
  • Salary: Negotiable
  • Job reference: 285451/002_1552684305
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 15/03/2019

QC Manager

Boulder, CO

Full-time, onsite, permanent

This company's leading pipeline candidate just attained POC data this past quarter, so they're looking to bolster up their Quality leadership.

Primary Responsibilities:

  • Manage QC testing and reporting - including stability of GMP starting materials, Drug Substance, and Drug Product - from clinical through commercial

  • Oversee all relevant vendor, CMO and CTO companies

  • Support Development, QA/QC, Regulatory Affairs, and Operations departments

  • Create/revise/review/approve SOPs, technical protocols and reports

Ideal Candidate:

  • BS/BA in science-related field or equivalent experience

  • 6+ years of related Quality Control experience

  • 4-5+ years of QC supervisory or management experience in biotech or pharmaceutical position in a GMP environment

  • Working knowledge of Chromatography, Mass Spec, FTIR, metals testing, vapor pressure and freezing point osmolality, purity by IP-RP-UPLC with UV, endotoxin, BSFS, sterility, and bioburden

  • Expertise in FDA cGMP regulations, ICH and FDA Guidances

  • Familiarity with oligonucleotides preferred

Apply today!

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