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Science Jobs in Aliso Viejo, CA

Senior Biologics Scientist

Trident Consulting

Aliso Viejo, CA

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JOB DETAILS
SKILLS
Analysis Skills, Analytical Chemistry, Analytical Development, Analytical Method Development, Analytical Method Validation, Assays, Biochemistry, Biological Assay, Biotech and Pharmaceutical, CMOS, Chemistry, Contract Research Organization (CRO), Cross-Functional, Decision Support, Droplet Digital PCR (ddPCR), Drug Development, Drug Manufacturing, Drug Products, Drug Release, Emerging Technology, FDA Requirements, GxP, High Performance Liquid Chromatography (HPLC), ICH Regulations, Identify Issues, Laboratory Analysis, Leadership, Liquid Chromatography-Mass Spectrometry (LC-MS), Manufacturing, Mentoring, Outsourcing, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Product Development, Project/Program Management, Quality Control, Real-time PCR (qPCR), Regulations, Regulatory Submissions, Research & Development (R&D), Securities and Exchange Commission (SEC), Stability Analysis, Team Player, Technical Writing, Trend Analysis, Writing Skills
LOCATION
Aliso Viejo, CA
POSTED
7 days ago
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

About the Company

T

Trident Consulting

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