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Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

The **Senior Microbiology Manager** provides strategic leadership and technical oversight for all microbiological activities supporting the manufacture of Selution SLR™ drug-eluting balloon combination products. This role is responsible for ensuring compliance with global regulatory requirements for combination products, including device and drug cGMPs, and for establishing robust microbiological controls across manufacturing, sterilization, and external suppliers.

The Senior Microbiology Manager leads a team responsible for environmental monitoring, bioburden and endotoxin control, supporting sterilization validation and monitoring, and microbiological risk management. The role partners closely with Quality, Manufacturing, R&D, Regulatory, and external contract manufacturers to ensure product safety, quality, and regulatory compliance throughout the product lifecycle.

Key Responsibilities

+ Provide leadership and technical oversight for all microbiology activities supporting drug-eluting balloon manufacturing.

+ Develop and maintain the microbiology strategy in alignment with combination product regulatory requirements (FDA, EU MDR, ISO).

+ Establish, build, mentor and manage a team of microbiology professionals.

+ Oversee environmental monitoring programs, including cleanroom classification, trending, and excursion management.

+ Ensure effective control and trending of bioburden, endotoxin, and microbial contamination for raw materials, in-process, and finished products.

+ Lead regulatory delegated PMA activities in relation to microbiology, this includes PMA direct support, FDA inspections as the microbiology SME for a combination device product.

+ Drive Vertical Integration of key services, this includes mapping required operations support, establishing an integration strategy, developing a financial ROI model, obtaining funding and leading the organization through the integration resulting in regulatory approved in-house facilities/services.

+ Provide microbiological input to risk management (ISO 14971), design changes, process changes, and investigations.

+ Ensure timely investigation and closure of microbiology-related nonconformances, deviations, and CAPAs.

+ Partner with Supplier Quality and Operations to qualify and oversee contract manufacturers, sterilization vendors, and microbiology testing laboratories.

+ Support drug coating and combination product processes, including microbiological risk assessment for drug substances, excipients, and coating operations.

+ Represent Microbiology during internal audits, supplier audits, and regulatory inspections.

+ Develop and maintain SOPs, validation protocols, and training related to microbiology, aseptic controls, and sterility assurance.

+ Drive continuous improvement initiatives related to contamination control, testing efficiency, and regulatory readiness.

+ Support budget planning, resource allocation, and long-term capability development for the microbiology function.

Qualifications

Required Qualifications

+ Bachelor’s degree in Microbiology, Biology, Biochemistry, or a related scientific discipline, or equivalent combination of education and experience.

+ 12+ years of experience in microbiology and sterility assurance within medical device, pharmaceutical, or combination product environments.

+ Strong working knowledge of GMP, ISO 13485, FDA QSR, EU MDR, and combination product regulations.

+ Hands-on experience with environmental monitoring, bioburden, endotoxin testing, and sterilization validation.

+ Proven leadership experience managing technical teams.

+ Strong investigation, problem-solving, and communication skills.

Preferred Qualifications

+ Master’s degree in Microbiology or related field.

+ Experience with drug-device combination products or drug-coated medical devices.

+ Familiarity with radiation sterilization and interaction with contract sterilization providers.

+ Professional certifications (e.g., ASQ, microbiology-related certifications).

+ Experience supporting global regulatory submissions and inspections.

Working Conditions

+ Office, laboratory, cleanroom, and manufacturing environments

+ Travel up to 20% for supplier, contract manufacturer, and sterilization site audits

+ Must comply with GMP, ISO 13485, EHS, and cleanroom requirements

Pay / Compensation

The expected pre-tax pay rate for this position is $139,700 - $200,200 per year. 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.

Preferred Qualifications

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 teammates’ 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.

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**Job Locations** _US-CA-Irvine_

**ID** _2025-12384_

**Category** _Quality/Regulatory_

**Position Type** _Regular Full-Time_

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact [email protected]