MSD

Director, Quality Control

MSD

full-time

Posted on:

Location Type: Hybrid

Location: West Point • Pennsylvania • United States

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Salary

💰 $173,200 - $272,600 per year

Job Level

Lead

About the role

  • Define and execute a global strategy for biologic critical reagents across the Large Molecule product lifecycle.
  • Establish governance, policies, and procedures for reagent selection, qualification, characterization, release, change control, storage, distribution, and disposal.
  • Drive reagent lifecycle management, including change control, comparability assessments, requalification, and retirement.
  • Lead a team responsible for qualification of cell banks, reference materials, in-house standards, and assay controls.
  • Ensure reagent quality and fitness-for-purpose through adherence to acceptance criteria, stability programs, compliance standards, and ongoing monitoring.

Requirements

  • 10+ years of experience in large molecule (biologics/vaccines) development, engineering, analytical sciences, or reagent development in relevant industries, including 4+ years in leadership roles.
  • Technical knowledge of biologic reagents and analytical methods (e.g., ELISA, SPR/BLI, SDS-PAGE, SEC, HPLC, qPCR, sequencing, cell-based assays).
  • Strong understanding of GMP/GxP requirements for large molecule commercial reagents as per global agency (e.g., FDA, EMA, and ICH) expectations for reference standards and analytical reagents.
  • Demonstrated experience in supplier qualification, contract negotiation, and external partnership management.
  • Experience with LIMS, inventory/reagent management, ELN, and electronic documentation and training/compliance systems.
  • Excellent leadership, communication, and stakeholder-management skills, with a track record of leading complex investigations and driving corrective and preventive actions.
Benefits
  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
biologic reagentsanalytical methodsELISASPR/BLISDS-PAGESECHPLCqPCRsequencingcell-based assays
Soft Skills
leadershipcommunicationstakeholder managementproblem-solvinginvestigationcorrective actionspreventive actions