Director, Drug Product

Primary Function of Position

This position will lead the drug product function within the CMC department. The Director of Drug Product will oversee all 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. The Director 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.

• Lead and manage internal and external teams including direct reports contractors and consultants; ensure effective onboarding training and execution of responsibilities. Foster a collaborative transparent culture and clear communication to achieve milestones and deliver high-quality outputs.

• 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.

• 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 CDMO partners in process 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 cross-functionallypartnering with Quality Assurance Regulatory Affairs and other CMC groups to drive successful drug product development and regulatory readiness.

• 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.

• Manage tech transfer activities from development to manufacturing ensuring solutions are scalable robust and transferable into commercial supply.

• Lead investigations and implement Corrective Action/Preventive Action CAPAs in partnership with quality as needed to resolve issues related to manufacturing testing or compliance.

• Serve as co-owner and collaborate with Analytical Colleague to manage the drug product stability programs.

• Well versed with scale-up and post-approval activities.

Qualifications :

Basic Qualifications

• Ph.D. in Pharmaceutical Sciences Chemical Engineering or related discipline with a minimum of 10 years small molecule drug product development experience in the biopharmaceutical industry.

• Demonstrated management experience with direct reports including hiring mentoring and team development.

• Successful application of Quality by Design (QbD) principles to drug product formulation and process development.

• Proven track record in leading drug product programs from preclinical through commercialization and regulatory approval.

• In-depth knowledge of FDA and ICH guidelines pertaining to drug product development and registration.

• Direct experience overseeing CDMOs and external partners including contract negotiations and risk management.

• Experience authoring and defending regulatory CMC sections for IND/NDA filings.

• Strong project management and leadership skills with the ability to prioritize and manage multiple projects simultaneously.

• Thorough understanding of cGMP requirements regulatory documentation and working in a regulated manufacturing environment.

• Proactive solutions-oriented mindset with the ability to anticipate potential hurdles resolve risks and keep projects on track for timely delivery.

• Excellent analytical critical thinking and communication skills

• Ability to travel up to 30%

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.

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