- 1-year contract opportunity - W2 (No C2C)
- Compensation: $60 - $90/hr
- 100% Remote
Intuitive Surgical, in cooperation with our recruitment partner Raise, are hiring. We’re a global technology leader in minimally invasive care and a pioneer of robotic-assisted surgery. Working closely with hospital teams, we’re developing integrated solutions that help enable physicians to get patients back to what matters most. Our technology has been used in nearly 10 million operations across 67 countries.
Together, we’ve dedicated more than two decades for innovating for better care through enhanced experiences, improved efficiencies, and reduced cost of care. In this role, you will join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients.
Primary Function of Position:
This position is for an experienced analytical professional to serve as an analytical lead and point of contact for Intuitive’s small molecule programs.
The Principle Analytical Scientist will work closely with colleagues across Technical Operations, Product Quality, and Regulatory CMC to drive the completion of final NDA methods, analytical control strategies, and specifications supporting successful process scale-up, validation, and commercial manufacture and launch.. They will identify and manage external partners supporting method development, analytical testing, and characterization across Intuitive’s late-phase and emerging commercial product portfolio. The principle Analytical Scientist will grow as a subject matter expert within and outside the department and help drive the commercialization of Intuitive’s late-phase pipeline as part of this growing, dynamic team.
Roles & Responsibilities:
- Be a recognized subject matter expert in support of late-phase product development, apply broad and deep analytical knowledge and experience to the material characterization and testing of drug substances and drug products.
- Provided technical guidance for troubleshooting/investigating complex analytical issues. Quickly and effectively resolved complex analytical issues and deviation/investigations.
- Collaborate with cross-functional technical operations, quality, and regulatory CMC partners to deliver on the integrated program CMC strategy.
- Lead the development of robust analytical control strategies to support process scale-up, validation, and commercial manufacturing, apply knowledge and direct experience to ensure the appropriate methodologies are in place and the methods are validated in accordance to the regulatory guidelines.
- Provide technical input for selecting external contractors and manage day-to-day analytical activities for the respective projects.
- Design, support, and analyze method transfer and validation activities across a late-phase portfolio of small molecules
- Author and review CMC sections of regulatory submissions and lead responses to questions and requests for additional information
- Identify and advocate for new and emerging technologies in analytical and physical characterization analysis
Skills, Experience, Education, & Training:
- Demonstrated expertise in late-phase analytical development, method transfer, validation, and stability program design and execution
- Experience with managing and guiding external testing laboratories during late-phase method optimization and NDA-level validations
- Experienced in QbD principles and the design, implementation, analysis, and presentation of process DOE data in regulatory submissions
- Subject matter proficiency in the analytical development with experience in test method development, HPLC, GC, titrations, spectroscopic methods, and physical characterization techniques such as X-ray powder diffraction, DSC, and TGA
- Knowledge and the ability to interpret and draw conclusions from data from analytical techniques employed across drug substance and drug product development
- Ability to troubleshoot analytical methods and testing issues, determine causes and possible solutions
- Experience managing trend analysis and supporting analytical method life-cycle management and continuous improvement
- Proven knowledge of cGMPs and associated regulatory and quality compliance in the pharmaceutical development and manufacturing environment
- Strong organizational, project management, and communication skills
Education
- Ph.D. in Chemistry, Analytical Chemistry, or related discipline with 8+ years' work experience. Similarly, a B.S. / M.S. with 15+ years' of relevant work experience
Intuitive is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
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.
Please note that this is a contract role providing services to Intuitive through our direct sourcing partner, Raise who manages Intuitive’s Contractor Talent Community. If you are selected for this role, you will be employed by Raise and will not be an employee of Intuitive.
Work with an Award Winning Employer:
- Best Places to Work, Glassdoor Employees’ Choice, 2019 (#12 of 100), 2020 (#7 of 100)
- America’s Best Midsized Employers, Forbes, 2019 (#149 of 500)
- Top 150 Places to Work in Healthcare, Becker’s Hospital Review, 2019
- Top CEOs, Glassdoor, 2019 (#9 of 100)
Raise and Intuitive are Equal Employment Opportunity Employers. 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 all qualified applicants with arrest and conviction records in accordance with fair chance laws.
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