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Director, Quality Control - Raw Materials

Forge Biologics
Location
Columbus, Ohio
Posted
20 days ago
Department
Quality Control - RM
What they actually want (must-haves)
  • Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology, or related discipline
  • 8+ years of experience in leadership, management, or supervisory roles, preferably within the Gene Therapy/Cell Therapy industry
  • Comprehensive experience with analytical methods used for raw materials testing
  • Expert-level knowledge of raw material requirements described in global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
  • Working knowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry, and molecular biology techniques
  • Expert-level knowledge of CMC analytical and regulatory requirements
Nice to have
  • Experience starting up, scaling, or managing multiple QC laboratories or testing groups
  • Hands-on or leadership experience with analytical instrumentation troubleshooting, laboratory equipment qualification, computerized laboratory systems, and implementation of new technologies or laboratory workflows
  • Experience in high-level interactions with domestic and international Regulatory agencies
  • Experience building, managing, or improving QC raw material programs, GMP testing operations, laboratory readiness activities, or supplier/material qualification processes
  • Experience with laboratory quality systems, including OOS/OOT investigations, deviations, CAPAs, change controls, data integrity expectations, and inspection readiness activities
What the job really is

The Director of Quality Control (Raw Materials) at Forge Biologics will lead the QC department focused on raw material testing and management. This role involves strategic leadership, collaboration with various departments, and ensuring compliance with regulatory requirements while overseeing the development of raw material qualification programs. The director will also handle quality-related issues and contribute to documentation and reporting processes.

Benefits
  • Health, dental and vision insurance starting your first day with 90% of premiums covered for you and your family
  • Competitive paid time off plan
  • 12 weeks of fully paid parental leave
  • Annual bonus opportunities for all full-time team members
  • 401(k) with company match
  • Special employee discounts, including childcare and dependent care savings
Things to weigh
  • No salary listed
  • Role involves significant leadership responsibilities and collaboration across multiple departments
  • Fast-paced, matrixed team environment may require adaptability to changing priorities
Job score3.4/5
Benefits5/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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