Senior Biologics Scientist
Job in
San Ramon, Contra Costa County, California, 94583, USA
Listed on 2026-07-09
Listing for:
Trident Consulting
Full Time
position Listed on 2026-07-09
Job specializations:
-
Research/Development
Research Scientist, Pharmaceutical Science/ Research, Medical Science
Job Description & How to Apply Below
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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- Manages analytical activities with:
- CROs
- CMOs
- Reviews outsourced analytical work.
- Ensures project quality, timelines, and compliance.
- Strong understanding of:
- Quality Systems
- Drug Product Manufacturing
- Validation
- Analytical lifecycle management
- Supports QC laboratories with robust analytical methods and product specifications.
- 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.
- 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.
- 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
Position Requirements
10+ Years
work experience
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