Director, Drug Product

Intuitive•Sunnyvale, CA

About The Position

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. 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 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. 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.

Requirements

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%

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 solving—balancing innovation with the fastest path to approval.
Collaborate cross-functionally—partnering 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.