Head of Product, Healthcare Job at Intuitive Surgical, Inc. in in Sunnyvale

Director, Drug Product (Finance) It started with a simple idea: what if surgery could be less invasive and recovery less painful? As a global leader in robotic-assisted surgery and minimally invasive care , our technologieslike 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. If you're ready to contribute to something bigger than yourself and help transform the future of healthcare , you'll find your purpose here. The Director of Drug Product will oversee all small molecule drug product development activities for Intuitive's latestage 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 nonclinical, 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. Develop and execute phaseappropriate 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. 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. 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 crossfunctionallypartnering 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 (CAPA) in partnership with quality, as needed, to resolve issues related to manufacturing, testing, or compliance. 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. Indepth 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, solutionsoriented mindset with the ability to anticipate potential hurdles, resolve risks, and keep projects on track for timely delivery. Ability to travel up to 30%. 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 COVID19. 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. 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.For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or 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. We provide marketcompetitive compensation packages, inclusive of base pay, incentives, benefits, and equity. The target compensation ranges are listed. Shift: Day