Job Description

Primary Function of Position

This position will serve as a drug product development lead within the CMC department. This role will oversee small molecule drug product development activities for Intuitive's late-stage development programs, ensuring timely regulatory submissions and the successful commercialization of these products. The role is responsible for formulation development, process optimization, technology transfer, and drug product manufacturing at external CDMOs to support non-clinical, clinical, and commercial activities. This role will ensure scientific and technical standards are robust, data packages support regulatory filings, and quality controls are implemented in partnership with Quality Assurance and Regulatory Affairs.

Roles and Responsibilities

• Develop and execute phase-appropriate strategies for the accelerated development of small molecule drug products, aligning with program goals and regulatory expectations.
• Foster a collaborative, transparent culture and clear communication to achieve milestones and deliver high-quality outputs.
• Lead and provide oversight of internal, and external teams, including direct reports, contractors, and consultants; ensure effective onboarding, training, and execution of responsibilities.
• Provide technical leadership to Contract Development and Manufacturing Organizations (CDMOs), ensuring development programs are on track and compliant with regulatory and project & overall program objectives.
• Manage tech transfer activities from development to manufacturing, ensuring solutions are scalable, robust, and transferable into commercial supply.
• Develop and implement comprehensive control strategies for excipients, container closure, and final drug product. Translate understanding into actionable formulation and process requirements for robust manufacturing.
• Direct formulation development, guiding work according to Quality by Design (QbD) principles, driving specification justification studies, process characterization, and validation to identify critical process parameters (CPPs), establish proven acceptable ranges (PARs), and characterize critical quality attributes (CQAs).
• Drive continuous improvements to drug product development by leveraging new technologies, risk management, and problem solving-balancing innovation with the fastest path to approval.
• Collaborate with Analytical Colleagues to manage the drug product stability programs.
• Collaborate cross-functionally-partnering with functional groups within Fluorescence Imaging and the greater Intuitive Surgical Organization such as: Quality Assurance, Regulatory Affairs, Commercial, Product Launch, Program Management, Clinical Development to drive successful drug product development and regulatory readiness.
• Lead investigations and implement Corrective Action/Preventive Action CAPAs in partnership with quality, as needed, to resolve issues related to manufacturing, testing, or compliance.
• Author and review regulatory documents, contributing to key sections of Investigational New Drug (IND) and New Drug Application (NDA) submissions related to pharmaceutical development and manufacturing.

Qualifications

Primary Function of Position

This position will serve as a drug product development lead within the CMC department. This role will oversee small molecule drug product development activities for Intuitive's late-stage development programs, ensuring timely regulatory submissions and the successful commercialization of these products. The role is responsible for formulation development, process optimization, technology transfer, and drug product manufacturing at external CDMOs to support non-clinical, clinical, and commercial activities. This role will ensure scientific and technical standards are robust, data packages support regulatory filings, and quality controls are implemented in partnership with Quality Assurance and Regulatory Affairs.

Roles and Responsibilities

• Develop and execute phase-appropriate strategies for the accelerated development of small molecule drug products, aligning with program goals and regulatory expectations.
• Foster a collaborative, transparent culture and clear communication to achieve milestones and deliver high-quality outputs.
• Lead and provide oversight of internal, and external teams, including direct reports, contractors, and consultants; ensure effective onboarding, training, and execution of responsibilities.
• Provide technical leadership to Contract Development and Manufacturing Organizations (CDMOs), ensuring development programs are on track and compliant with regulatory and project & overall program objectives.
• Manage tech transfer activities from development to manufacturing, ensuring solutions are scalable, robust, and transferable into commercial supply.
• Develop and implement comprehensive control strategies for excipients, container closure, and final drug product. Translate understanding into actionable formulation and process requirements for robust manufacturing.
• Direct formulation development, guiding work according to Quality by Design (QbD) principles, driving specification justification studies, process characterization, and validation to identify critical process parameters (CPPs), establish proven acceptable ranges (PARs), and characterize critical quality attributes (CQAs).
• Drive continuous improvements to drug product development by leveraging new technologies, risk management, and problem solving-balancing innovation with the fastest path to approval.
• Collaborate with Analytical Colleagues to manage the drug product stability programs.
• Collaborate cross-functionally-partnering with functional groups within Fluorescence Imaging and the greater Intuitive Surgical Organization such as: Quality Assurance, Regulatory Affairs, Commercial, Product Launch, Program Management, Clinical Development to drive successful drug product development and regulatory readiness.
• Lead investigations and implement Corrective Action/Preventive Action CAPAs in partnership with quality, as needed, to resolve issues related to manufacturing, testing, or compliance.
• Author and review regulatory documents, contributing to key sections of Investigational New Drug (IND) and New Drug Application (NDA) submissions related to pharmaceutical development and manufacturing.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate's qualifications, consistent with applicable law.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.