CMC Analytical Development Lead - Late-Stage

Barrington James; San Jose (CA); On-site; USD 190,000 - 270,000; Full time

Job summary

Barrington James is recruiting for an experienced analytical leader to guide late-stage small molecule development within a biopharmaceutical client. The role is hands-on, bridging strategic decisions and day-to-day delivery across CMC activities, method transfer, validation, and stability programs.

You will act as the technical lead for external partners (CDMOs/CROs), oversee Phase 3 readiness and regulatory filings, review documentation, ensure data integrity, and collaborate with Process

Qualifications

• PhD preferred in a relevant field.
• Strong expertise in small molecule analytical development.
• Experience supporting late-stage programs through submission.
• Understanding of global regulatory expectations (ICH, GMP).
• Experience supervising external partners (CDMOs/CROs).
• Hands-on method validation and stability studies.
• Experience contributing to regulatory CMC documentation (Module 3).
• Strong data integrity and GMP understanding.

Responsibilities

• Serve as primary analytical contact for external partners, guiding challenges.
• Oversee late-stage analytics, method transfer, refinement, validation for DS/DP.
• Review partner documentation including validation protocols and reports.
• Lead analytical readiness for Phase 3 and commercial manufacturing.
• Guide stability programs and degradation studies.
• Contribute to control strategy development and impurity assessment.
• Review results for traceability and quality standards.
• Prepare content for regulatory submissions (IND/NDA/MAA).

Skills

Small molecule analytics

Regulatory knowledge(ICH GMP)

CDMO oversight

Method validation

Stability studies

CMC documentation (Module 3)

Cross-functional collaboration

Strategic thinking

Education

PhD in a relevant field

Job description

Barrington James is recruiting for an experienced analytical leader to guide late-stage small molecule development within a biopharmaceutical client. The role is hands-on, bridging strategic decisions and day-to-day delivery across CMC activities, method transfer, validation, and stability programs.

You will act as the technical lead for external partners (CDMOs/CROs), oversee Phase 3 readiness and regulatory filings, review documentation, ensure data integrity, and collaborate with Process