Drug Substance Director

Company: Intuitive Surgical
Location: Sunnyvale
Posted on: July 3, 2025

Job Description:

Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care. Job Description Primary Function of Position: This position will lead the drug substance function of the CMC department. This individual will manage all small molecule drug substance development activities for both of Intuitive’s late stage development programs to ensure timely regulatory filings. This individual will be responsible for chemical route scouting, process optimization, technology transfer and drug substance manufacturing activities at external CMO’s to support the non-clinical and clinical portions of each program. This individual will ensure that (1) appropriate scientific and technical standards are established; (2) robust data are available to support regulatory filings; and (3) in partnership with quality assurance, that appropriate quality controls are implemented and executed. Roles & Responsibilities: Develop and execute strategy that is phase-appropriate and well positioned for accelerated development of small molecule programs. Lead and manage internal personnel, contractors, and consultants, ensuring effective onboarding, training, and task execution. Foster a collaborative work environment, allocate resources efficiently, and maintain clear communication channels to achieve project milestones and high-quality outcomes. Provide direction and technical expertise to Contract Manufacturing Organizations (CMO) partners, guiding CMC work to ensure development programs are on track, aligned with project objectives, and meet regulatory requirements. Develop a comprehensive control strategy for starting materials, intermediates, and drug substance, and convert this understanding into specific unit operation requirements to achieve a robust manufacturing process. Guide CMO to execute process development studies according to the principal of Quality by Design, specification justification studies to establish limits, process characterization studies to identify proven acceptable ranges (PARs) of critical process parameters (CPPs), including identification of edge of failure, characterization of drug substances to identify critical quality attributes (CQAs). Provide direction to the CMO in terms of drug substance development strategies and technical expertise. Drive continuous improvements in the drug substance development process through technological innovations, risk management, and problem solving whilst balancing against fastest path to approval. Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and other CMC functional groups, to drive the successful development of drug substances. Actively contribute to writing key pharmaceutical development sections of regulatory documents IND/IMPD/NDA. Qualifications Skills, Experience, Education, & Training: Minimum Ph.D. in Organic Chemistry, Chemical Engineering, or a related field with a minimum of 10 years’ of small molecule biopharmaceutical industry experience. Management experience with direct reports, including hiring, training, and team development. Well-versed and demonstrated success in the application of QbD principles. Proven track record of successfully leading small molecule programs from preclinical, clinical and validation stages, through regulatory approval. Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, NMPA, ICH) pertaining to drug substance development and commercialization. Understanding of product life-cycle management is beneficial Experience managing contract manufacturing organizations (CMOs) and external partners/vendors. Proven negotiation skills in contract management as well as influencing key stake holders in QA and regulatory with robust risk management assessments. Excellent leadership and project management skills, with the ability to effectively prioritize and manage multiple projects simultaneously. In-depth understanding of cGMP principles, documentation requirements and experience working in a regulated manufacturing environment. Proactive mindset with a focus on anticipation of potetntial development hurdles, problem-solving, and planning to meet project timeline goals. Strong analytical and critical thinking abilities, with a keen attention to detail. 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 Employment Opportunity / Affirmative Action 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. EEO and AA Policy 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 salary ranges are listed. 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. 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 salary ranges are listed. Base Salary Range Region 1: $201,900 USD - $302,900 USD Base Salary Range Region 2: $171,600 USD - $257,500 USD Shift: Day Travel: 25% of the time Workplace Type: Onsite - This job is fully onsite.

Keywords: Intuitive Surgical, Arden-Arcade , Drug Substance Director, Science, Research & Development , Sunnyvale, California