Senior Scientist I, Bioassay
About The Position
The Senior Scientist I, Analytical Development, Biologics CMC supports analytical development for biologic therapeutics by establishing and advancing phase-appropriate cell-based bioassay, potency, functional, and binding assay capabilities. This hands-on role independently develops, optimizes, qualifies, transfers, and manages 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 supports scientifically rigorous, regulatory-relevant, cost-effective, and timely potency assay strategies through laboratory execution, technical ownership, and collaboration with Discovery, Translational Sciences, Process Development, Quality, Regulatory, CDMOs, CTLs, and external partners. It contributes to internal bioassay capabilities and may provide technical guidance, training, and work direction to junior scientists, research associates, consultants, CDMOs, CTLs, and other external partners. No direct people management responsibility is required. The work is primarily in laboratory and office settings, with potential exposure to biological materials, chemical reagents, hazardous materials, and extreme cold. The office is described as a modern collaborative space with equipment including dual monitors and ergonomic chairs.
Requirements
- Hands-on experience developing complex cell-based bioassays or functional assays from concept through optimization, qualification, troubleshooting, documentation, and method transfer.
- 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.
- Effective communication, collaboration, presentation, data interpretation, organization, prioritization, and problem-solving skills in a fast-paced, cross-functional CMC environment.
- Strong ownership, scientific curiosity, attention to detail, laboratory discipline, and commitment to high-quality technical execution.
- Ph.D. in a relevant life sciences discipline with relevant industry experience; or a master's degree in a relevant discipline with 5+ years of relevant industry experience; or a bachelor's degree in a relevant discipline with 7+ years of relevant industry experience; or an equivalent combination of education and experience.
Nice To Haves
- Experience with mammalian cell culture, assay-ready cells, transient transfection or engineered cell models, flow cytometry, plate-based assays, and functional potency readouts.
- Working knowledge of biologics CMC, analytical control strategy, phase-appropriate method development, and CDMO/CTL interactions.
Responsibilities
- Develop complex cell-based bioassays and potency assays from initial concept through optimization, qualification, and method transfer for biologic therapeutics.
- Perform 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 for 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 internal bioassay capabilities, including cell culture workflows, flow cytometry practices, plate-reader methods, data analysis tools, and critical reagent management.
- Provide technical guidance, training, and work direction to junior scientists, research associates, consultants, CDMOs, CTLs, and other external partners.
Benefits
- 401(k) plan with generous company contributions
- Group medical, dental, and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program, or a sales-based incentive plan for field sales staff
- Opportunity to purchase company stock
- Long-term incentives
- 15 accrued vacation days in the first year
- 17 paid holidays, including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
