Intuitive · 1 day ago
Director, Drug Product
Sunnyvale, CA
Full-time
Onsite
Director/Executive
$202K/yr - $303K/yr
10+ years expIntuitive is a global leader in robotic-assisted surgery and minimally invasive care. The Director of Drug Product will lead the drug product function within the CMC department, overseeing small molecule drug product development activities and ensuring timely regulatory submissions and successful commercialization.
Health CareManufacturingMedical Device
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
Qualification
Required
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%
Benefits
Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity
Company
Intuitive
Intuitive designs and manufactures robotic-assisted surgical systems.
10001+ employees
H1B Sponsorship
Intuitive has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)
Funding
Current Stage
Public CompanyTotal Funding
$5MKey Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M
Leadership Team
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Myriam Curet
Executive Vice President & Chief Medical Officer
Recent News
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2026-01-23
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