Cell-Based Assays Senior or Principal Scientist, Analytical Development
1 month ago
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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