Senior/Principal Scientist Cell Based Potency Assay

Scorpion Therapeutics; Lexington (MA); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Medical/dental/vision

401(k) match

Disability insurance

Life insurance

Tuition reimbursement

Volunteer time off

Holidays

Well-being benefits

Sick time and vacation

Job summary

Scorpion Therapeutics in Lexington, MA is seeking a Senior/Principal Scientist to lead cell-based potency assay development across biologics programs, including qualification, validation, transfer, and lifecycle management. You will translate MOA insights into MOA-driven analytical methods and oversee mammalian cell culture and statistical analyses for product characterization and regulatory submissions.

The role also involves preparing documentation, coordinating with Process Development, QC,

Qualifications

• Ph.D./MS/BS with 3+/9+/11+ years of relevant experience as Senior/Principal
• Expertise in cell-based potency assays and MOA-driven methods for biologics/vaccines
• Advanced statistics for bioassays and proficiency with readouts (luminescence, ELISA, flow)

Responsibilities

• Provide technical leadership for cell-based potency assay development, qualification, validation, transfer, and lifecycle management across biologics programs.
• Translate MOA insights into phase-appropriate analytical methods supporting product characterization and regulatory submissions.
• Lead potency assays and mammalian cell culture work; perform statistical analysis and establish assay acceptance criteria.
• Prepare and review technical documentation (reports, SOPs, protocols, CMC/regulatory sections).
• Coordinate with cross-functional and external stakeholders and mentor team members.

Skills

Cell-based potency assays

MOA-driven methods

Biologics/regulatory experience

Statistical analysis

Mammalian cell culture

Flow cytometry

LIMS

Education

Ph.D.

MS

BS

Tools

ELN/LIMS

Job description

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)