Senior Analytical Development Lead (Small Molecules)

Intuitive Surgical, Inc. in; Sunnyvale (CA); On-site; USD 168,000 - 252,000; Full time

Job summary

Intuitive Surgical, Inc. in Sunnyvale is seeking an experienced Analytical Development Senior Manager (Finance) to provide strategic and technical leadership for late‑stage small molecule programs progressing toward regulatory submission.

The role leads external analytical resources, ensures method transfer/validation, and contributes to IND/NDA/IMPD filings, aligning with ICH/cGMP and QbD throughout the process. Ideal candidates hold a Ph.D.

Qualifications

• Ph.D. in Analytical Chemistry or related field with 10+ years in industry.
• Experience with Small Molecule DS/DP in late-stage development.
• Proven track record coordinating with CDMOs/CMOs.
• Expert knowledge of ICH Q1–Q14 and cGMP.
• Strong technical writing for Module 3 submissions.

Responsibilities

• Provide technical oversight of external analytical resources at CDMOs.
• Lead transfer, optimization, and validation of analytical methods for DS and DP.
• Review CDMO protocols, reports, and data for validation and stability studies.
• Assess risks related to analytical control and impurity profiling.
• Draft and edit Module 3 sections for regulatory submissions.
• Respond to health authority IRs on analytical topics.
• Ensure QbD alignment and regulatory expectations.

Skills

Analytical chemistry expertise

CDMO/CMO management

Late-stage development (Phase 3)

ICH guidelines (Q1–Q14)

Regulatory filing support (IND/NDA)

Technical leadership

Education

Ph.D. in Analytical Chemistry

M.S. in Analytical Chemistry

Tools

cGMP knowledge

Quality by Design (QbD)

Job description

Intuitive Surgical, Inc. in Sunnyvale is seeking an experienced Analytical Development Senior Manager (Finance) to provide strategic and technical leadership for late‑stage small molecule programs progressing toward regulatory submission.

The role leads external analytical resources, ensures method transfer/validation, and contributes to IND/NDA/IMPD filings, aligning with ICH/cGMP and QbD throughout the process. Ideal candidates hold a Ph.D.