Drug Product, Dir.

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 Intuitives 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 solvingbalancing innovation with the fastest path to approval.
• Collaborate with Analytical Colleagues to manage the drug product stability programs.
• Collaborate cross-functionallypartnering 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 Intuitives 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 solvingbalancing innovation with the fastest path to approval.
• Collaborate with Analytical Colleagues to manage the drug product stability programs.
• Collaborate cross-functionallypartnering 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 employeeswho 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 governments 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 employeesstart 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 candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates 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.

Remote Work :

No

Employment Type :

Full-time