Associate Principal Scientist – Bioassay, Cell Based Sciences, AR&D
Core
Developing and optimizing potency assays (immune binding and cell-based) for large molecule biologics including therapeutic proteins, monoclonal antibodies, and antibody-drug conjugates.
Role type
Associate Principal Scientist (Bioassay, Cell Based Sciences)
Builds
Potency assays and methods for large molecule portfolio
Domain
Biopharmaceuticals / Large Molecule Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Potency assay development, Immune binding assays, Cell-based functional assays, Stable cell line generation, Cytotoxicity assays, ELISAs, Flow cytometry, Reporter gene assays, Quality by Design (QbD), Design of Experiments (DOE), Statistical data interpretation, Regulatory submission authoring, Scientific mentoring
Preferred skills
New modality-based therapy development, High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS)
Technologies
SoftMax Pro, JMP, PLA software, GraphPad Prism, Microsoft Office tools
Responsibilities
Define potency strategy and develop/optimize immune binding and cell-based assays, Conduct non-GMP qualification and robustness studies, Support potency method transfers and validation at GxP labs, Represent potency on cross-functional teams, Author and review regulatory submissions, Provide scientific mentoring to junior scientists
Seniority
Senior, hands-on IC with mentoring responsibilities
