Senior Scientist, Analytical Development (Large Molecules)

Trident Consulting; Irvine (CA); Presencial; USD 130.000 - 210.000; Jornada completa

Descripción de la vacante

Trident Consulting is seeking a Sr. Scientist – Analytical Development (Large Molecules/Biologics) to join an on-site team in Aliso Viejo, CA. This full-time role emphasizes analytical method development and collaboration with CROs/CMOs to drive drug development programs.

The candidate will design and execute analytical strategies, interpret complex data, and contribute to regulatory submissions. A Ph.D. or M.S.

Formación

• Ph.D. or M.S. in biochemistry or related field with extensive pharma industry experience.
• 8+ years for Ph.D. or 10+ years for M.S. in large molecule analytics and development.

Responsabilidades

• Provide analytical development for large molecules and biologics across drug development stages.
• Troubleshoot and generate high-quality scientific data.
• Lead investigations and interpret stability data for regulatory submissions.
• Collaborate with CROs/CMOs and SMEs across teams.
• Prepare CMC sections of INDs/NDAs and respond to regulatory questions.
• Mentor scientists and communicate project status to management.

Conocimientos

Analytical development

Chromatography

Team collaboration

CRO/CMO oversight

Regulatory submissions

Educación

Ph.D. in biochemistry

M.S. in biochemistry

Herramientas

HPLC

UPLC

LC-MS

ELISA

cIEF

Descripción del empleo

Trident Consulting is seeking a Sr. Scientist – Analytical Development (Large Molecules/Biologics) to join an on-site team in Aliso Viejo, CA. This full-time role emphasizes analytical method development and collaboration with CROs/CMOs to drive drug development programs.

The candidate will design and execute analytical strategies, interpret complex data, and contribute to regulatory submissions. A Ph.D. or M.S.