Position located in Waltham, MA

Responsibilities:

• Lead the development, optimization, and qualification of cell-based potency assays that evaluate the biological activity of cell therapy products.
• Design and execute functional assays to support product characterization, comparability assessments, stability studies, and manufacturing process changes.
• Develop and transfer analytical methods used to characterize and monitor Master and Working Cell Banks while ensuring methods are suitable for GMP environments.
• Analyze complex experimental data, identify assay trends, and apply statistical approaches to evaluate assay performance, reproducibility, and long-term reliability.
• Generate and review technical documentation including SOPs, protocols, validation reports, method transfer packages, specifications, and regulatory support documents.
• Collaborate with cross-functional teams across Process Development, Manufacturing, Quality, and Regulatory to advance analytical strategies throughout product development.
• Present scientific findings and provide technical recommendations to internal stakeholders and external partners.
• Mentor junior scientists and contribute to the continuous improvement of analytical technologies and laboratory practices.

Requirements:

• PhD in Immunology, Cell Biology, Molecular Biology, Biomedical Engineering, or a related discipline with 2+ years of industry experience, or an MS/BS with 6–10+ years of relevant biopharmaceutical experience.
• Strong background developing and qualifying cell-based potency assays for cell therapy, biologics, immunotherapy, or related advanced therapeutic products.
• Hands-on experience with functional assays such as cytokine secretion, immune cell activation, cytotoxicity, proliferation, or other mechanism-of-action assays.
• Demonstrated ability to independently design experiments, interpret complex data, troubleshoot assay performance, and drive analytical strategy.