Associate Dir/Director of External Manufacturing, Allendale, NJ
Genetix Biotherapeutics(27 days ago)
About this role
The Associate Director/Director, External Drug Product Manufacturing serves as the on-site, accountable representative to a manufacturing partner in Allendale, NJ, ensuring alignment between Genetix and external production partners for commercial products. The role is focused on maintaining reliable, compliant, and cost-effective manufacturing of advanced therapies while supporting strategic planning and vendor relationships. The ideal candidate brings extensive biopharma and cell & gene therapy experience and a track record of leading external manufacturing partnerships.
Required Skills
- CDMO Management
- Tech Transfer
- Scale Up
- Manufacturing Oversight
- Quality Compliance
- Regulatory Support
- Vendor Management
- Process Validation
- Change Control
- CAPA Management
+2 more
Qualifications
- Bachelor's degree in Engineering, Life Sciences, or Biotechnology
- Advanced degree (MS, PhD, MBA) preferred
- 10+ years biopharmaceutical manufacturing experience
- 5+ years cell & gene therapy experience
About Genetix Biotherapeutics
genetixbiotx.comGenetix Biotherapeutics (formerly bluebird bio) is a biopharmaceutical company focused on developing and delivering transformative genetic therapies for people living with sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy. The company advances clinical programs and patient support services to bring novel gene-based treatments to individuals with severe inherited blood and neurological disorders. Headquartered in Somerville, MA, Genetix provides medical information, runs clinical trials, and offers dedicated patient support and outreach.
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