Cell-Based Assays Senior or Principal Scientist, Analytical Development

1 month ago


Cambridge, United States Garuda Therapeutics Full time

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:

  • 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.


Required Qualifications:

  • 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.


Preferred Qualifications:

  • 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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