Principal Scientist, CMC Analytics – Analytical Chemistry

Latigo Biotherapeutics, Inc.; San Francisco (CA); Híbrido; USD 180 000 - 240 000; Tempo integral

Resumo da oferta

Latigo Biotherapeutics, Inc. is seeking an Associate Director/Principal Scientist, CMC Analytical Chemistry in the San Francisco Bay Area.

This role oversees analytical development and testing at CMOs, develops QC methods for drug substance and product, and collaborates with QA and Regulatory to ensure cGMP compliance and regulatory submissions. The candidate will manage reference standards, stability programs, and data documentation, contributing to IND/IMPD and NDA filings while working across

Qualificações

• PhD with 8+ years in analytical chemistry or BS/MS with 10–15 years in industry.
• Strong knowledge of GLP/cGMP and regulatory guidance for analytical development.
• Experience managing CROs/CMOs for drug substance and drug product analyses.

Responsabilidades

• Oversee phase-appropriate analytical activity at CMOs including method development, qualification and validation.
• Develop specifications for raw materials, intermediates, excipients and drug product.
• Design and manage stability programs and shelf-life guidance.
• Author and review analytical reports and regulatory filings.
• Support regulatory submissions by drafting analytical sections of INDs, NDAs/IMPDs.
• Represent analytical in CMC teams and coordinate cross-functional timelines.
• Review cGMP documents and manage QC review of data.

Conhecimentos

Analytical method development

Regulatory submissions (CMC)

Project management

cGMP/GLP knowledge

Formação académica

PhD with 8+ years in analytical chemistry

BS/MS in chemistry with 10–15 years industry experience

Ferramentas

Microsoft Office

Excel

Descrição da oferta de emprego

Latigo Biotherapeutics, Inc. is seeking an Associate Director/Principal Scientist, CMC Analytical Chemistry in the San Francisco Bay Area.

This role oversees analytical development and testing at CMOs, develops QC methods for drug substance and product, and collaborates with QA and Regulatory to ensure cGMP compliance and regulatory submissions. The candidate will manage reference standards, stability programs, and data documentation, contributing to IND/IMPD and NDA filings while working across