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Senior Biologics Scientist

Trident Consulting

  • Aliso Viejo, CA
  • 30+ days ago

    Highlights

    Strong background in biological potency assays, cell-based assays, and analytical characterization of biologics and protein therapeutics. Hands-on expertise supporting CMC analytical activities , regulatory submissions, and cross-functional product development.

    Numbers & Facts

    LocationAliso Viejo, CA

    Description

    Role: Senior Biologics Scientist / Analytical Development Scientist
    Location: Aliso Viejo CA
    Type: Fulltime

    Core Expertise
    • 8+ years (Ph.D.) or 10+ years (M.S.) in Analytical Development supporting large molecule biologics from early clinical development through commercialization.
    • Extensive experience in analytical method development, qualification, validation, transfer, and lifecycle management.
    • Strong background in biological potency assays, cell-based assays, and analytical characterization of biologics and protein therapeutics.
    • Hands-on expertise supporting CMC analytical activities, regulatory submissions, and cross-functional product development.

    Analytical Techniques
    • Strong hands-on experience with:
      • HPLC / UPLC
      • IEX-HPLC
      • SEC-HPLC
      • LC-MS
      • CE
      • cIEF
      • MSD
      • ELISA
      • ddPCR
      • qPCR
      • Octet
      • Biacore
    • Experience characterizing:
      • Potency
      • Purity
      • Biological activity
      • Stability
      • Aggregation profile
      • Impurities
      • Drug release performance
    Method Development & Validation
    • Develops, optimizes, validates, and transfers analytical methods.
    • Supports QC with:
      • Method validation
      • Method transfer
      • Product specifications
      • Release testing
    • Independently troubleshoots complex analytical issues throughout product development.
    Stability & Data Analysis
    • Oversees stability studies.
    • Performs trend analysis and data interpretation.
    • Evaluates release and stability data to support scientific decision-making.
    • Generates high-quality analytical reports and technical documentation.
    Regulatory & CMC Experience
    • Authors analytical sections for:
      • IND
      • NDA
      • CMC documentation
    • Prepares responses to regulatory agency questions.
    • Strong knowledge of:
      • FDA regulations
      • ICH guidelines
      • GxP compliance
    • Supports regulatory inspections and submissions.
    Large Molecule Drug Development
    • Supports biologics throughout:
      • Early research
      • Clinical development
      • Process development
      • Commercialization
    • Experience with protein formulations and drug product characterization.
    • Collaborates with protein/peptide engineering teams on biologic design and development.
    Leadership & Project Management
    • Serves as Analytical Lead on CMC project teams.
    • Coordinates analytical activities across multiple programs.
    • Manages priorities, timelines, and project deliverables.
    • Provides scientific leadership and mentoring to junior scientists.
    • Represents Analytical Development in cross-functional meetings.
    External Collaboration
    • Manages analytical activities with:
      • CROs
      • CMOs
    • Reviews outsourced analytical work.
    • Ensures project quality, timelines, and compliance.
    Quality & Manufacturing Support
    • Strong understanding of:
      • Quality Systems
      • Drug Product Manufacturing
      • Validation
      • Analytical lifecycle management
    • Supports QC laboratories with robust analytical methods and product specifications.
    Scientific & Technical Skills
    • Strong analytical problem-solving and troubleshooting skills.
    • Maintains expertise in emerging analytical technologies.
    • Evaluates and implements innovative analytical methodologies.
    • Excellent scientific writing and presentation skills.
    Communication & Collaboration
    • Excellent verbal and written communication.
    • Works effectively in multidisciplinary teams.
    • Collaborates with R&D, Manufacturing, Quality, Regulatory Affairs, and external partners.
    • Communicates technical findings through reports, presentations, and project meetings.
    Education
    • Ph.D. in Biochemistry, Analytical Chemistry, Immunoanalytical Chemistry, or related field with 8+ years of experience, or
    • M.S. in a related scientific discipline with 10+ years of experience.
    • 6+ years of pharmaceutical industry experience in:
      • Large molecule analytical development
      • Drug product analysis

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