Senior Analytical Development Lead – Large Molecules

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

Job summary

Trident Consulting is seeking a Senior Analytical Development Scientist / Analytical Lead in the Irvine/Aliso Viejo area. The role leads analytical method development, validation, and transfer for large molecules, collaborating with CROs/CDMOs and cross‑functional teams to support regulatory submissions.

The candidate will manage stability studies, interpret analytical data, mentor staff, and drive multiple projects to IND/NDA readiness, in a fast‑paced biotech environment.

Qualifications

• Ph.D. with 8+ years or M.S. with 10+ years in Biochemistry/Analytical Chemistry.
• 6+ years of pharma industry experience in large‑molecule analytics and regulatory submissions.
• Hands‑on method development, validation, transfer, and troubleshooting.
• Knowledge of GxP, ICH, FDA regulations and stability studies.

Responsibilities

• Develop, validate, and transfer analytical methods for large molecules, proteins, and peptides.
• Perform hands‑on laboratory experiments and operate analytical instruments.
• Develop and troubleshoot biological potency and cell‑based assays.
• Manage stability studies, trend analysis, and analytical data interpretation.
• Collaborate with CROs/CDMOs and serve as the analytical lead on CMC project teams.
• Prepare technical reports and support IND/NDA regulatory submissions.
• Mentor scientists and manage multiple projects.

Skills

Large‑molecule analytics method dev

Hands‑on troubleshooting

CRO/CDMO collaboration

Education

Ph.D. with 8+ years or M.S. with 10+ years in Biochemistry/Analytical Chemistry

Tools

HPLC

UPLC

SEC-HPLC

IEX-HPLC

LC-MS

CE

cIEF

ELISA

MSD

ddPCR

qPCR

Octet

Biacore

Job description

Trident Consulting is seeking a Senior Analytical Development Scientist / Analytical Lead in the Irvine/Aliso Viejo area. The role leads analytical method development, validation, and transfer for large molecules, collaborating with CROs/CDMOs and cross‑functional teams to support regulatory submissions.

The candidate will manage stability studies, interpret analytical data, mentor staff, and drive multiple projects to IND/NDA readiness, in a fast‑paced biotech environment.