Senior Scientist I, Functional Biocharacterization & Impurities

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. #J-18808-Ljbffr Scorpion Therapeutics