Backed by GV.
About the role
We are looking for a highly motivated Senior Manager/Associate Director External Manufacturing, with a strong background in CDMO management of viral vector and ancillary materials production. As a key contributor within the External Manufacturing organization, you’ll lead front-line oversight of viral vector and ancillary material production, helping to drive the development of our first autologous cell therapy program targeting solid tumors In addition, you’ll establish a new phase appropriate manufacturing...
What they're looking for
- Bachelor's Degree in Life Sciences, Engineering, or related discipline with, Senior Manager 8+ (MS 6+), Associate Director 10+ (MS 8+) years of experience in manufacturing or MS&T roles in the biotech/pharma industry
- Extensive experience designing and implementing batch records, EBRs, and MES integrated systems
- Deep experience in quality systems, deviation management, root cause analysis, change control, and risk management in a GMP environment
- Proven application of Lean manufacturing and operational excellence tools and techniques to improve manufacturing cycle times and right first-time execution
- Strong understanding of GMP regulations, quality requirements, and global regulatory expectations for advanced therapies
- Proficiency in developing and managing SOWs, change orders, contract negotiations, CDMO budget planning, financial reporting, and budget management
More about this role
About Us …
Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer.
We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
We are looking for a highly motivated Senior Manager/Associate Director External Manufacturing, with a strong background in CDMO management of viral vector and ancillary materials production. As a key contributor within the External Manufacturing...
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