Garuda Therapeutics, a biotechnology company focused on developing off-the-shelf human hematopoietic stem cell-based cellular therapies, is seeking a highly motivated Associate Director / Director to join its growing team. The full-time role will be a key CMC leadership member, focused on preparing and implementing Garuda’s Regulatory strategy. Working closely within the R&D and CMC Departments, the ideal candidate will be responsible for helping bring much-needed therapies to patients. The position will be located in Natick, MA, or Cambridge, MA.
Key Responsibilities Include:
- Providing leadership and strategic direction to support Garuda’s overall Regulatory plan
- Supporting the R&D and CMC teams to enable successful INDs, CTAs, and Health Authority interactions
- Ensuring that all CMC-related documentation is clear, concise, and meets necessary requirements
- Reviewing clinical and nonclinical documents to ensure messaging is consistent with program strategy
- PhD with 3+ years of related experience, MS with 7+ years of related experience, or BS with 10+ years of related experience
- Direct experience in Regulatory CMC, demonstrated by a record of successful INDs/CTAs
- Working knowledge of FDA, EMA, and ICH guidelines
- Attention to detail and careful record-keeping
- Excellent organizational skills and ability to manage multiple projects
- Excellent oral and written communication skills
- Flexible team player excited to collaborate with internal and external partners
- Experience with cell and gene therapies; experience with iPSC-derived cell products is highly preferred
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