Job 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:
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:
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 Show more Skills
Analysis Skillsunmatched
Analytical Chemistryunmatched
Analytical Developmentunmatched
Analytical Method Developmentunmatched
Analytical Method Validationunmatched
Assaysunmatched
Biochemistryunmatched
Biological Assayunmatched
Biotech and Pharmaceuticalunmatched
CMOSunmatched
Chemistryunmatched
Contract Research Organization (CRO)unmatched
Cross-Functionalunmatched
Decision Supportunmatched
Droplet Digital PCR (ddPCR)unmatched
Drug Developmentunmatched
Drug Manufacturingunmatched
Drug Productsunmatched
Drug Releaseunmatched
Emerging Technologyunmatched
FDA Requirementsunmatched
GxPunmatched
High Performance Liquid Chromatography (HPLC)unmatched
ICH Regulationsunmatched
Identify Issuesunmatched
Laboratory Analysisunmatched
Leadershipunmatched
Liquid Chromatography-Mass Spectrometry (LC-MS)unmatched
Manufacturingunmatched
Mentoringunmatched
Outsourcingunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Process Developmentunmatched
Product Developmentunmatched
Project/Program Managementunmatched
Quality Controlunmatched
Real-time PCR (qPCR)unmatched
Regulationsunmatched
Regulatory Submissionsunmatched
Research & Development (R&D)unmatched
Securities and Exchange Commission (SEC)unmatched
Stability Analysisunmatched
Team Playerunmatched
Technical Writingunmatched
Trend Analysisunmatched
Writing Skillsunmatched
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