Senior Scientist I, 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.

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 or engineered cell models, flow cytometry, plate-based assays, and functional potency readouts is strongly preferred.

Knowledge, Skills and Abilities:

• Advanced knowledge of cell-based bioassay and potency assay development for biologic therapeutics, including mammalian cell culture, flow cytometry, receptor-expression analysis, functional assay design, and binding/kinetic methods such as SPR or BLI.
• Strong understanding of potency as a critical quality attribute and ability to translate product mechanism of action into scientifically justified assay strategies, biological readouts, cell models, controls, and acceptance criteria.
• Ability to develop assays with limited precedent, troubleshoot complex assay performance issues, interpret cell-based assay, flow cytometry, and binding data, and make practical CMC development recommendations.
• Working knowledge of phase-appropriate method development, qualification, comparability, method transfer, and lifecycle management for biologics.
• Technical writing skills for assay protocols, SOPs, development reports, qualification or transfer documents, comparability assessments, regulatory-supporting summaries, and investigation reports.

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