Trident Consulting · 1 month ago
Senior Biologics Scientist
United States
Full-time
Remote
Senior Level
8+ years expTrident Consulting is seeking a Senior Biologics Scientist to lead analytical development for large molecule biologics. The role involves method development, regulatory submissions, and collaboration with cross-functional teams to support product development from early clinical stages to commercialization.
Big DataArtificial Intelligence (AI)Enterprise SoftwareInformation TechnologyAnalyticsEnterprise Resource Planning (ERP)Machine Learning
Responsibilities
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
Supports regulatory inspections and submissions
Supports biologics throughout:
Early research
Clinical development
Process development
Commercialization
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
Supports QC laboratories with robust analytical methods and product specifications
Qualification
Required
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, and drug release performance
Develops, optimizes, validates, and transfers analytical methods
Supports QC with method validation, method transfer, product specifications, and 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, and CMC documentation
Prepares responses to regulatory agency questions
Strong knowledge of FDA regulations, ICH guidelines, and GxP compliance
Supports regulatory inspections and submissions
Supports biologics throughout early research, clinical development, process development, and 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 and CMOs
Reviews outsourced analytical work
Ensures project quality, timelines, and compliance
Strong understanding of Quality Systems, Drug Product Manufacturing, Validation, and 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 and drug product analysis
Company
Trident Consulting
Trident Consulting expertise in big data, AI & analytics, cloud, infrastructure, ERP, Java frameworks and technologies, Engineering and R&D.
51-200 employees
H1B Sponsorship
Trident Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
90%
Represents job field similar to this job
Engineering and Development
Management and Executive
Sales
Trends of Total Sponsorships
*2025 (2)
2024 (2)
2023 (3)
2022 (2)
2021 (7)
2020 (15)
Funding
Current Stage
Growth StageLeadership Team
Shabana Siraj
CEO and Founder
Company data provided by crunchbase