Research Associate/Sr. Research Associate, Drug Product Development

Role Summary

Role: Research Associate/Sr. Research Associate, Drug Product Development. The role is to develop, characterize, implement, and support iPSC-derived cell therapies. You will culture, differentiate, and characterize iPSCs and their effector derivatives, design and perform process/product development studies, and analyze data. Collaboration with internal and external teams is essential, and strong scientific, organizational, and communication skills are required.

Responsibilities

• Execute high-quality cell culture and differentiation experiments, ensuring accuracy, reproducibility, and adherence to established protocols.
• Perform and analyze flow cytometry assays, interpreting and presenting data to guide ongoing research and development efforts.
• Collaborate cross-functionally with scientists, process engineers, and analytical teams to meet project milestones and optimize workflows.
• Maintain detailed and organized electronic laboratory notebooks (ELNs), documenting procedures, observations, and experimental outcomes in compliance with internal quality standards.
• Stay current with emerging literature and technologies in stem cell biology, immunology, and cell therapy to inform experimental design and innovation.
• Contribute to process development initiatives, helping translate bench-scale findings into scalable, robust processes for manufacturing.
• Assist in authoring and reviewing CMC documents for regulatory filings (e.g. IND, BLA) in collaboration with other parts of organization.
• Collaborate with internal and external team members.
• Foster a collaborative and scientifically rigorous team culture.

Qualifications

• B.S. or M.S. degree in a relevant biological, technical, or cell engineering field with the following relevant professional experience: B.S.: 2 - 4 years; M.S.: 0 - 2 years

Skills

• Experience with mammalian cell culture and media optimization.
• Understanding of cell biology/physiology and/or engineering fundamentals. Experience with induced pluripotent stem cells (iPSC) is desirable.
• Understanding of bioprocess characterization and validation concepts, cGMP, and GLP.
• Dynamic and culturally astute team-player, scientifically rigorous with excellent communication skills.
• Experience with designing, execution, and troubleshooting new protocols and assays.
• Excellent written and verbal communication skills.
• Attention to detail and accuracy, ability to think critically, and work in a fast-paced setting to meet deadlines and prioritize across multiple projects/platforms.