Drug Product, Dir.

Intuitive; Sunnyvale (CA); On-site; USD 189,000 - 231,000; Full time

Job summary

Intuitive is seeking a Drug Product Development Lead to oversee small molecule DP development within the CMC department, driving formulation, process optimization, and tech transfer with external CDMOs. The role ensures timely regulatory submissions and robust manufacturing readiness for late-stage programs.

You will shepherd QbD-driven development, establish CPPs, PARs, CQAs, and collaborate across QA, Regulatory, and Commercial teams to deliver compliant, scalable solutions.

Qualifications

• Lead small molecule drug product development in the CMC department for late-stage programs.
• Oversee formulation development, process optimization, tech transfer to external CDMOs.
• Ensure scientific rigor and data packages support regulatory filings (IND/NDA).
• Apply QbD, CPPs, PARs, CQAs to robust manufacturing.

Responsibilities

• Develop phase-appropriate strategies for accelerated small molecule DP development.
• Lead internal and external teams, ensuring onboarding and training as needed.
• Provide technical leadership to CDMOs for regulatory-compliant development.
• Manage tech transfer to manufacturing and scalable solutions.
• Drive control strategies for excipients, containers, and final DP.
• Collaborate on stability programs with Analytical teams.
• Lead CAPAs with Quality Assurance to resolve manufacturing issues.
• Draft and review regulatory documents for IND/NDA submissions.

Skills

Drug product development

CMC leadership

Regulatory submissions

QbD principles

Tech transfer

Quality by Design

CAPA management

Cross-functional collaboration

Job description

• Ways of Working: Onsite - This job is fully onsite.
• Employee Type: Employee
• Min. Salary Region 1: 210300 USD
• Global Job Level (HCM): Professional 6 (15)
• Min. Salary Region 2: 0 USD

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.

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 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.