Cell-Based Assays Senior or Principal Scientist, Analytical Development
Cell-Based Assays Senior or Principal Scientist, Analytical Development
Garuda Therapeutics
Cambridge, MA
See who Garuda Therapeutics has hired for this role
Garuda Therapeutics is pioneering the development of off-the-shelf hematopoietic stem cell (HSC)-based cellular therapies for treating patients with blood, bone marrow, immune, and metabolic disorders. The company uses state-of-the-art technologies in developmental biology, gene-editing, stem cells, and mechanobiology to engineer safe, compatible HSCs in scalable quantities to transform the lives of patients in need of an HSC-transplant.
Key Responsibilities:
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Key Responsibilities:
- Lead the development and qualification of diverse cellular assays, including ELISA (Enzyme-Linked Immunosorbent Assay) and ddPCR (droplet digital PCR), to characterize and release human pluripotent and hematopoietic stem cells
- Execute in vitro assays to support process development activities and ensure the quality of cellular products
- Collaborate closely with cross-functional teams within Garuda Therapeutics, providing technical expertise and guidance
- Oversee the technical transfer and implementation of key assays across teams, ensuring consistency and reliability
- Actively contribute to the authoring of technical documents supporting regulatory submissions, such as IND/CTA filings
- PhD in a relevant scientific discipline with 3-5+ years of related experience, or MS with 7-10+ years of related experience, or BS with 10+ years of related experience
- Strong expertise in cell culture techniques and developing/qualifying cell-based assays, including ELISA and ddPCR methods
- Proficiency in data analysis and interpretation, particularly in the context of molecular and cellular assays
- Experience transferring assays to contract testing labs and ensuring their robustness and reproducibility
- Demonstrated excellence in experimental design, execution, and analysis
- Ability to think critically, troubleshoot effectively, and propose innovative solutions to assay challenges
- Excellent organizational skills, attention to detail, and meticulous record-keeping
- Outstanding written and verbal communication skills, with the ability to articulate complex scientific concepts effectively
- Flexibility and adaptability to manage multiple projects simultaneously and collaborate in a fast-paced team environment
- Highly self-motivated with a commitment to excellence and the flexibility to accommodate occasional weekend work if necessary
- Experience with additional analytical techniques relevant to cellular characterization, such as flow cytometry or qPCR
- Hands-on experience in induced pluripotent stem cell (iPSC) culture maintenance, differentiation protocols, and hematopoietic stem cell (HSC) culture
- Previous experience in designing, optimizing, and validating assays for the characterization of stem cell-derived products
- Knowledge of Good Manufacturing Practices (GMP) and regulatory requirements for analytical methods in cell therapy product development
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Research, Analyst, and Information Technology -
Industries
Internet Publishing
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