Director of Combination Device Analytical Science, Selution

Cordis • Irvine, CA

408d • $169,400 - $242,550 • Remote

About The Position

The Director of Combination Device Analytical Science at Cordis is responsible for leading the in-vitro drug performance characterization of Sirolimus in a Drug Eluting Balloon platform. This role involves overseeing the design control development for drug performance, including test methods, procedures, and acceptance criteria. The director will serve as the primary contact for regulatory body interactions regarding drug in-vitro performance, ensuring compliance and effective communication with various stakeholders.

Requirements

• Ph.D. in Analytical Chemistry or a related field, with postdoctoral experience desirable
• Minimum of 20 years of experience in analytical chemistry combination device development
• Proven expertise in developing and validating analytical methods for Sirolimus-based products
• In-depth knowledge of analytical techniques and instrumentation (e.g., HPLC, GC, dissolution, spectroscopy)
• Strong understanding of quality management systems, regulatory requirements, and industry standards (e.g., FDA, ISO, USP/NF)
• Experience with regulatory bodies representing combination device development

Nice To Haves

• Experience in combination device product development
• Strong organizational leadership skills
• Global regulatory body interaction experience
• Fluency in additional languages

Responsibilities

• Identify, establish and validate GMP level Sirolimus drug characterization test methods
• Act as the primary contact for regulatory bodies regarding drug in-vitro performance queries
• Establish, develop and deliver analytical services in support of PMA
• Lead PMA efforts by inputting, writing & reviewing in-vitro drug performance material
• Supervise the operations of the QC analytical laboratory
• Provide scientific guidance and expertise to the organization
• Ensure continuity of the analytical QC laboratory with operations scaling

Benefits

• Competitive salary
• Health insurance
• 401k retirement plan
• Paid time off
• Professional development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree