Drug Product, Dir.

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

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.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

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.

Base Compensation Range Region 1: $210 300 USD - $315 500 USD
Base Compensation Range Region 2: $0 USD - $0 USD
Shift: Day
Workplace Type: Onsite - This job is fully onsite.