Senior Manager, Analytical Development – Late-Stage Small Molecules

Intuitive; Sunnyvale (CA); On-site; USD 151,000 - 185,000; Full time

Benefits offered by this job

Market-competitive compensation

Equal Opportunity Employer

Job summary

Intuitive Surgical in Sunnyvale, CA seeks an experienced analytical chemistry leader to guide late-stage small molecule programs through regulatory filing. The role requires deep expertise in analytical method development, validation, CMC documentation, and management of external CDMOs.

You will serve as the primary technical liaison with CDMOs, ensuring robust method validation, seamless technology transfer, and rigorous quality control, while drafting Module 3 for IND/NDA filings and

Qualifications

• Ph.D. in Analytical Chemistry or related field with 10+ years of industry experience.
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Responsibilities

• Provide strategic and technical leadership for late-stage small molecule programs through regulatory submission.
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Skills

Analytical chemistry

Late-stage development

GMP compliance

Data integrity

Technical writing

Regulatory submissions

CDMO management

HPLC/LC-MS

Education

PhD in Analytical Chemistry

MS in Chemistry

Tools

HPLC/LC-MS

CMC documentation

Job description

Intuitive Surgical in Sunnyvale, CA seeks an experienced analytical chemistry leader to guide late-stage small molecule programs through regulatory filing. The role requires deep expertise in analytical method development, validation, CMC documentation, and management of external CDMOs.

You will serve as the primary technical liaison with CDMOs, ensuring robust method validation, seamless technology transfer, and rigorous quality control, while drafting Module 3 for IND/NDA filings and