Lead Analytical Chemist, Selution

Overview

Cordis is a pioneering medical technology company specializing in groundbreaking solutions for cardiovascular and peripheral vascular diseases. Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.

If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then this is the place for you. Join us, and let’s improve the wellbeing of millions, together.

We are the people behind the people who keep saving lives.

We are seeking an experienced and detail oriented Lead Analytical Chemist to join the Quality Control Analytical Laboratory. The successful candidate will provide technical leadership and ensure compliance with regulatory standards for the testing of drug combination products. This role requires a strong background in analytical chemistry and a thorough understanding of laboratory compliance in the pharmaceutical and medical device industries.

Responsibilities

• Scientific leadership in ensuring operational continuity and stability of the analytical QC lab
• Primary analytical QC lab representative in cross functional operations meetings & projects
• Change management: Facilitate significant scaling of the Irvine site operations capacity
• Manage lab deviations i.e. OOS/OOT and disposition of test results supporting clinical and commercial product
• Identify and drive optimization of test methods i.e. test run time, equipment upgrades etc
• Drive GLP: Ensure compliance with applicable regulations, standards, and quality management systems (e.g., FDA GMP, QSR, ISO 13485, ISO 17025).
• Establish and maintain robust quality control processes to ensure reliability of analytical data.
• Develop and implement standard operating procedures (SOPs) and best practices for the analytical laboratory.
• Develop existing quality metrics (KPIs) to drive continuous improvement.
• Prepare and review technical documents, including protocols, reports, and regulatory submissions.
• Stay current with industry trends, regulatory requirements, and advancements in analytical techniques.
• Mentor and provide technical guidance to junior chemists and other team members
• Perform analytical chemistry related activities as needed i.e. maybe required to test in times of significant lab demand
  
  
  

Qualifications

• BS or BA degree in Chemistry or related field (required)
• Minimum of 8 years work experience working in a GMP Quality Control Laboratory environment
• In-depth knowledge and expertise of analytical techniques, instrumentation, quality management systems, data integrity, and laboratory investigations
• Excellent problem-solving, critical thinking, and decision-making abilities
• Strong commitment to laboratory safety, compliance, and ethical conduct
• Moderate office work
• Must be able to lift and carry up to 15 lbs.
• Fluent in English
  
  
  

Pay / Compensation

The expected pre-tax pay rate for this position is $107,800 - 154,000

Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.