Senior Biologics Analytical Scientist – Method Lead

Trident Consulting; Irvine (CA); On-site; USD 118,000 - 148,000; Full time

Benefits offered by this job

Potential bonus and stock awards

Job summary

Trident Consulting is seeking a Senior Biologics Analytical Scientist in Aliso Viejo, CA. The role focuses on method development, validation, and transfer for large-molecule drug development, leading projects, and coordinating with CROs/CDMOs.

You will perform hands-on lab work, operate instruments, and support regulatory submissions. The position emphasizes independent leadership, cross-functional collaboration, and adherence to GxP, ICH, and FDA guidelines.

Qualifications

• PhD with 8+ years of experience or MS with 10+ years in Biochemistry/Analytical Chemistry or related field.
• At least 6 years of pharma industry experience in large-molecule analytics and regulatory submissions.
• Strong hands-on experience in method development, validation, troubleshooting, and transfer for large molecules.
• Ability to independently initiate, lead, and execute lab projects and resolve technical problems.
• Experience with CROs/CMOs/CDMOs and providing technical direction.
• Experience with stability studies, trend analysis, and analytical characterization.
• Knowledge of GxP, ICH, FDA requirements and regulatory filings.
• Strong scientific communication, writing, project mgmt, and cross-functional collaboration.

Responsibilities

• Develop, validate, and transfer analytical methods for large molecules.
• Lead hands-on laboratory experiments and operate analytical instruments.
• Support analytical characterization of proteins, peptides, and formulations.
• Conduct stability studies and trend analyses to inform decisions.
• Coordinate analytical activities with internal teams and CROs/CDMOs.
• Serve as analytical lead on CMC project teams for regulatory submissions.
• Develop methodologies for drug release, potency, and purity assessments.
• Prepare protocols, reports, and documentation for IND/NDA submissions.
• Collaborate with protein/peptide engineering teams on novel proteins.

Skills

Method development

Regulatory submissions

CRO/CDMO oversight

Team leadership

GxP/ICH/FDA compliance

Large molecule analytics

Education

PhD or MS in Biochemistry/Analytical Chemistry

Tools

HPLC/UPLC

IEX-HPLC

SEC-HPLC

CE

cIEF

ELISA

ddPCR

qPCR

Octet

Job description

Trident Consulting is seeking a Senior Biologics Analytical Scientist in Aliso Viejo, CA. The role focuses on method development, validation, and transfer for large-molecule drug development, leading projects, and coordinating with CROs/CDMOs.

You will perform hands-on lab work, operate instruments, and support regulatory submissions. The position emphasizes independent leadership, cross-functional collaboration, and adherence to GxP, ICH, and FDA guidelines.