Senior/Principal Scientist Cell Based Potency Assay
Takeda
August 11, 2026
On-site
Lexington, MA
$154,400 - $242,550 USD yearly
Clinical Research and Development
Join as a Senior/Principal Scientist, Cell Based-Potency Assay Development. Provide technical leadership for cell-based potency assay development, qualification, validation, transfer, and lifecycle management across biologics programs. Translate mechanism of action insights into phase-appropriate analytical methods supporting product characterization, process development, GMP release/stability, comparability, regulatory submissions, and analytical control strategy. Lead and troubleshoot potency assays and mammalian cell culture work; perform statistical analysis (relative potency, dose-response modeling, curve fitting, parallelism/similarity, reference standard comparison) and establish assay acceptance criteria. Prepare/review technical documentation (reports, SOPs, protocols, CMC/regulatory sections). Coordinate with cross-functional and external stakeholders (Process Development, QC, Analytical Sciences, QA, Regulatory, CROs/labs) and independently resolve complex assay/cell culture/data/transfer issues. Provide training and mentoring; present results internally/externally as appropriate.
Qualifications (What you bring): Ph.D. (3+ years for Senior/7+ for Principal), MS (9+/13+), or BS (11+/15+) in relevant fields. Advanced expertise in cell-based potency assays/functional bioassays and MOA-driven methods for biologics/vaccines/cell/gene therapy. Advanced statistical expertise for bioassays (4-parameter logistic/nonlinear dose-response, parallelism/similarity, reference standard comparison, system suitability, acceptance criteria). Strong mammalian cell culture expertise and proficiency with readouts (luminescence/fluorescence/absorbance, ELISA, MSD, flow cytometry, reporter/neutralization assays). Knowledge of assay qualification/validation and GMP, data integrity, ELN/LIMS, SOPs, and regulatory expectations. Ability to lead complex workstreams and communicate/present; experience with regulatory/transfer documentation and working with CROs/labs; ability to mentor and work independently.
Benefits: Medical/dental/vision, 401(k) match, short-/long-term disability, basic life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation (new hires).
Application instructions: Apply via the “Apply” button.
Qualifications (What you bring): Ph.D. (3+ years for Senior/7+ for Principal), MS (9+/13+), or BS (11+/15+) in relevant fields. Advanced expertise in cell-based potency assays/functional bioassays and MOA-driven methods for biologics/vaccines/cell/gene therapy. Advanced statistical expertise for bioassays (4-parameter logistic/nonlinear dose-response, parallelism/similarity, reference standard comparison, system suitability, acceptance criteria). Strong mammalian cell culture expertise and proficiency with readouts (luminescence/fluorescence/absorbance, ELISA, MSD, flow cytometry, reporter/neutralization assays). Knowledge of assay qualification/validation and GMP, data integrity, ELN/LIMS, SOPs, and regulatory expectations. Ability to lead complex workstreams and communicate/present; experience with regulatory/transfer documentation and working with CROs/labs; ability to mentor and work independently.
Benefits: Medical/dental/vision, 401(k) match, short-/long-term disability, basic life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation (new hires).
Application instructions: Apply via the “Apply” button.