Senior Scientist I, Functional Biocharacterization & Impurities

Scorpion Therapeutics; Redmond (WA); On-site; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics in Redmond, WA seeks an experienced scientist to lead the development and validation of cell-based assay formats for biologics. The role includes mentoring staff, transferring methods to QC, and authoring technical documents.

The candidate will drive regulatory filings and participate in cross-functional teams, applying knowledge of assay development, MOA relationships, and analytical method strategies in a fast-paced environment.

Qualifications

• PhD/MS/BS in Biochemistry, Molecular/Cellular Biology, Chemical Engineering, Bioengineering, Chemistry, or related.
• ICH/USP guidelines for analytical and potency assay development/validation knowledge.
• Experience in development and validation of potency and analytical methods.

Responsibilities

• Serve as SME in development of cell-based assay formats for biologics programs.
• Lead a team to implement method development and phase-appropriate validation.
• Supervise and mentor direct reports; train junior staff.

Skills

Cell-based assays

Team leadership

Mentor staff

Regulatory documentation

Analytical method development

Flow cytometry

Education

PhD

MS

BS

Tools

SoftMax Pro

JMP

Microsoft Office

Job description

Responsibilities:

• Serve as a subject matter expert in development of cell-based assay formats for early and late phase biologics programs.
• Lead a team to implement method development and phase-appropriate validation for cell-based assays across formats.
• Supervise and develop direct reports; mentor and train junior staff.
• Transfer methods to Quality Control laboratory.
• Author technical documents.
• Participate in process development teams (potentially as potency lead and analytical team lead).
• Execute comparability and biosimilarity assessments.
• Lead technology development to improve throughput, efficiency, and onboard new technologies.
• Author and contribute to regulatory filing documents (IND, INDa, BLA, IMPD).
• Present data to internal teams, clients, conferences, and peer-reviewed journals.
• Lead cross-functional teams and initiatives.

Required Qualifications:

• PhD (3+ years), MS (5+ years), or BS (10+ years) in Biochemistry, Molecular/Cellular Biology, Chemical Engineering, Bioengineering, Chemistry, or related.
• Understanding of ICH/USP guidelines for analytical and potency assay development/validation.
• Experience in development and phase-appropriate validation of potency and methods.
• Experience managing and mentoring direct reports.
• Strong understanding of link between Mechanism of Action and analytical method development; effects of impurities on biological manufacturing.
• Technology development experience relevant to potency assays (e.g., FcgR effector function assays, large-scale cell banking, image/flow cytometry).
• Strong oral and written communication; ability to thrive in fast-paced, collaborative environments.

Preferred Qualifications:

• Experience with SoftMax Pro, JMP, and Microsoft Office.
• Experience with late-stage regulatory filings.