Drug Product Development Lead - Small Molecule

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 210,000 - 316,000; Full time

Job summary

Intuitive Surgical, Inc. is seeking a drug product development lead within the CMC department to steer small molecule drug product development for late-stage programs.

You will oversee formulation development, process optimization, and tech transfer to CDMOs to support regulatory submissions and commercialization. Responsibilities include leading cross-functional teams, driving QbD-based development, and ensuring robust quality controls in partnership with QA and Regulatory Affairs, with a focus

Qualifications

• Experience leading small molecule drug product development programs.
• Ability to manage tech transfer to CDMOs and ensure regulatory readiness.
• Strong collaboration with QA, Regulatory Affairs, and cross-functional teams.

Responsibilities

• Develop phase-appropriate strategies for accelerated small molecule development.
• Provide technical leadership to internal and external teams.
• Oversee tech transfer to manufacturing and ensure scalable solutions.
• Lead CAPAs and investigations with quality teams to resolve issues.
• Author and review regulatory documents for IND/NDA submissions.
• Collaborate with analytical teams on stability programs.

Skills

Regulatory compliance

CDMO oversight

Process optimization

Quality by Design

Technical leadership

Job description

Intuitive Surgical, Inc. is seeking a drug product development lead within the CMC department to steer small molecule drug product development for late-stage programs.

You will oversee formulation development, process optimization, and tech transfer to CDMOs to support regulatory submissions and commercialization. Responsibilities include leading cross-functional teams, driving QbD-based development, and ensuring robust quality controls in partnership with QA and Regulatory Affairs, with a focus