Senior Scientist , Bioassay

** SUMMARY/

JOB PURPOSE:

** The Senior Scientist I, Analytical Development, Biologics CMC will support CMC analytical development for biologic therapeutics by establishing and advancing phase-appropriate cell-based bioassay, potency, functional, and binding assay capabilities. This hands-on role will independently develop, optimize, qualify, transfer, and manage fit-for-purpose assays that reflect product mechanism of action and relevant critical quality attributes across ADCs, monoclonal antibodies, bispecifics, multispecifics, Fc-fusion proteins, VHH-Fc constructs, and other novel biologic modalities.  

The position exists to ensure scientifically rigorous, regulatory-relevant, cost-effective, and timely potency assay strategies through strong laboratory execution, technical ownership, and effective collaboration with Discovery, Translational Sciences, Process Development, Quality, Regulatory, CDMOs, CTLs, and external partners.
** ESSENTIAL DUTIES/RESPONSIBILITIES:
*** Develop complex cell-based bioassays and potency assays from initial concept through optimization, qualification, and method transfer for biologic therapeutics.
* Perform hands-on mammalian cell culture, transient transfection, engineered cell model development, receptor-expression confirmation, and assay-ready cell support.
* Develop and troubleshoot functional bioassays, including reporter-gene, cytotoxicity, proliferation/inhibition, receptor blockade, ADCC/CDC, and immune-cell engagement assays.
* Apply flow cytometry, ELISA or plate-based binding assays, SPR/BLI, and other orthogonal methods to support assay development, comparability, and structure-function understanding.
* Evaluate assay performance, robustness, system suitability, relative potency, parallelism, and critical assay parameters to enable phase-appropriate method qualification and transfer.
* Author and review assay procedures, development reports, qualification or transfer documents, technical summaries, and CMC-relevant regulatory supporting materials.
* Collaborate with Discovery, Translational Sciences, Process Development, Quality, Regulatory, CDMOs, CTLs, and external partners to align assay strategy with program needs.
* Contribute to building internal bioassay capabilities, including cell culture workflows, flow cytometry practices, plate-reader methods, data analysis tools, and critical reagent management.
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* SUPERVISORY RESPONSIBILITIES:

*** No direct people management responsibility is required. The incumbent may provide technical guidance, training, and work direction to junior scientists, research associates, consultants, CDMOs, CTLs, and other external partners.
** EDUCATION/EXPERIENCE/KNOWLEDGE &

SKILLS:

***
* Education:

*** Ph.D. in cell biology, immunology, molecular biology, biochemistry, bioengineering, biophysics, pharmaceutical sciences, analytical sciences, or a related life sciences discipline with relevant industry experience; or,
* Master’s degree in cell biology, immunology, molecular biology, biochemistry, bioengineering, biophysics, pharmaceutical sciences, analytical sciences, or a related life sciences discipline with 5+ years of relevant industry experience; or,
* Bachelor’s degree in cell biology, immunology, molecular biology, biochemistry, bioengineering, biophysics, pharmaceutical sciences, analytical sciences, or a related life sciences discipline with 7+ years of relevant industry experience; or,
* Equivalent combination of education and experience.
*
* Experience:

*** Hands-on experience developing complex cell-based bioassays or functional assays from concept through optimization, qualification, troubleshooting, documentation, and method transfer.
* Experience with mammalian cell culture, assay-ready cells, transient transfection…