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 developing Garuda’s analytical capabilities. Working closely within the R&D and CMC Departments, the ideal candidate will be responsible for leading analytical method development, qualification, and technology transfer, in addition to establishing a well-functioning analytical group that can perform a variety of analyses to characterize internal and external production runs. The position will be located in Natick, MA, or Cambridge, MA.
Key Responsibilities Include:
- Building in-house capabilities to develop a range of assays to characterize and release our pluripotent stem cell-derived cellular product
- Independently leading a team to develop and qualify cell and molecular biology-based assays
- Leading the technology transfer of qualified assays to contract testing labs
- Authoring technical documents (e.g., SOPs, protocols, reports, etc.) that support IND/CTA submissions
- Tracking and trending analytical data collected from production runs
- Organizing and communicating data to key stakeholders
Required Qualifications:
- PhD with 3+ years of related experience, MS with 7+ years of related experience, or BS with 10+ years of related experience
- Direct experience with qualifying cell and/or molecular-based assays and tech transferring them to contract testing facilities
- Strong leadership and problem-solving skills
- Attention to detail and careful record-keeping
- Excellent organizational skills and ability to manage multiple projects
- Excellent oral and written communication skills, able to write technical reports and protocols
- Flexible team player excited to collaborate with internal and external partners
- Authorized to legally work in US
Preferred Qualifications:
- Experience with cell and gene therapies; experience with iPSC-derived cell products is highly preferred
Please contact careers@garudatx.com to share your resume and learn more.
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