Forge Biologics
Director, Quality Control - Raw Materials
Columbus, Ohio · Director
Sponsorship not specifiedDetected 31 days ago
Supply ChainProcurementGMPqPCRCRISPRMolecular BiologyMass SpectrometryProtein AnalysisLeadershipCommunicationMentoring
Stay score
odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Community outcomes
No reports yet — be the first to help the next applicant.
About the role
- If you're driven by purpose and excited to make a tangible impact, this is where your journey begins.
- Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio.
- Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases.
Responsibilities
- Provides strategic leadership and guidance to the organization to develop and implement a material qualification program in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
- Create, review, and approve out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls.
Requirements
- 8+ years of experience in leadership, management, or supervisory roles, preferably within the Gene Therapy/Cell Therapy industry.
- Comprehensive experience with the 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.
- Working knowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry, and molecular biology techniques.
- Expert-level knowledge of raw material requirements described in global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
- <span d
Nice to have
- Bachelor's d egree in Chemistry, Biochemistry, Molecular Biology, or related discipline ( Master's Degree or PhD is preferred).
Skills
- Your Future with Us:
- to enable access to life-changing gene therapies and help bring them from ideas into reality.
- At Forge, your growth matters.
Company info
- Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities.
- Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality.
- Here, you won't just watch innovation happen - you'll be part of it.
Apply directly at Forge Biologics →Create a free account for alerts like thisView Forge Biologics immigration profile
This listing is sourced directly from Forge Biologics's careers page and normalized into a canonical job model.