Analytical Development Lead for Late-Stage Biopharma

Barrington James; San Jose (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Barrington James is seeking an experienced Senior Manager / Associate Director Analytical Development to lead analytical strategy for late-stage small molecules. You will act as the technical point of contact for external partners while aligning with internal CMC and regulatory goals to ensure robust, compliant methods and timely delivery.

The role demands hands-on leadership, strategic planning, and execution in a lean, fast-moving environment, with close interaction across Process Development,

Qualifications

• PhD preferred in a relevant scientific field.
• Experience with late-stage/registration programs for small molecules.
• Strong understanding of GMP and data integrity.
• Experience overseeing external CDMOs/CROs.
• Experience with method validation and stability studies.
• Regulatory CMC documentation (Module 3) experience.
• Ability to communicate complex data across functions.

Responsibilities

• Serve as the primary analytical contact for external partners.
• Oversee analytical activities across late-stage programs (DS/DP) transfer & validation.
• Approve partner docs including protocols and reports.
• Lead readiness for Phase 3 and commercial manufacturing.
• Guide stability programs and impurity assessments.
• Prepare regulatory submissions and respond to agencies.
• Collaborate with Process Development, Formulation, QA, and Regulatory.

Skills

Small molecule analytics

Analytical method validation

External partner management

Regulatory CMC documentation

GMP & data integrity

Phase 3 / commercial readiness

Cross-functional leadership

Communication

Education

PhD (preferred) in a relevant field

Job description

Barrington James is seeking an experienced Senior Manager / Associate Director Analytical Development to lead analytical strategy for late-stage small molecules. You will act as the technical point of contact for external partners while aligning with internal CMC and regulatory goals to ensure robust, compliant methods and timely delivery.

The role demands hands-on leadership, strategic planning, and execution in a lean, fast-moving environment, with close interaction across Process Development,