Senior Scientist, Biologics – Large Molecule Analytics Lead

Trident Consulting; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Trident Consulting seeks a Senior Scientist - Biologics in Aliso Viejo, CA, onsite. You will lead analytical development for large molecules, validate assays, and coordinate transfers to CROs/CMOs, supporting development from early studies to commercialization.

You will also oversee stability, interpret data for regulatory questions, and contribute to IND/NDAs documentation while mentoring teammates and collaborating across departments.

Qualifications

• PhD with 8+ years or MS with 10+ years in biochemistry or related field.
• 8+ years of pharmaceutical/biotech large molecule analytical development experience.
• Experience with regulatory submissions (INDs/NDAs) and GMP/ICH/GxP.

Responsibilities

• Develop, validate, and transfer analytical and potency assays for large molecules.
• Oversee stability studies and perform trend analyses for drug substances.
• Lead analytical activities on CMC project teams and interact with CROs/CMOs.
• Prepare protocols and technical sections for regulatory submissions and reports.

Skills

Leadership

Cross-functional collaboration

Regulatory awareness

Education

PhD in biochemistry or related field

MS in biochemistry or related field

Tools

HPLC

UPLC

IEX-HPLC

SEC-HPLC

LC-MS

ELISA

qPCR

ddPCR

Octet

Biacore

Job description

Trident Consulting seeks a Senior Scientist - Biologics in Aliso Viejo, CA, onsite. You will lead analytical development for large molecules, validate assays, and coordinate transfers to CROs/CMOs, supporting development from early studies to commercialization.

You will also oversee stability, interpret data for regulatory questions, and contribute to IND/NDAs documentation while mentoring teammates and collaborating across departments.