Senior Biologics Scientist II | Analytical & CMC Lead

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

Job summary

Trident Consulting seeks a Sr. Scientist II, Biologics in Aliso Viejo, CA to lead analytical development for large molecules, validate assays, and drive technology transfer. You will partner with cross‑functional teams, oversee CRO/CMO activities, and contribute to regulatory submissions.

The role demands hands‑on lab work, troubleshooting, and ability to manage multiple projects with strong communication.

Qualifications

• Analytical method development for large molecules.
• Ability to collaborate with cross-functional teams.
• Experience engaging with CROs and CMOs.
• Familiarity with regulatory/GxP environments.

Responsibilities

• Develop, validate, and transfer analytical and potency assay methods for large molecules.
• Oversee stability studies and conduct trend analysis.
• Coordinate activities with CROs/CMOs to ensure timely results.
• Act as analytical lead on CMC project teams and communicate findings.
• Prepare technical reports and contribute to regulatory submissions.
• Provide training and guidance to scientists in the team.

Skills

Analytical method development

Team collaboration

CRO/CDMO collaboration

Education

Ph.D. in biochemistry or related field

M.S. in biochemistry or related field with 10+ years

Tools

HPLC

UPLC

LC-MS

ELISA

qPCR

ddPCR

Biacore/Octet

Job description

Trident Consulting seeks a Sr. Scientist II, Biologics in Aliso Viejo, CA to lead analytical development for large molecules, validate assays, and drive technology transfer. You will partner with cross‑functional teams, oversee CRO/CMO activities, and contribute to regulatory submissions.

The role demands hands‑on lab work, troubleshooting, and ability to manage multiple projects with strong communication.