Apply on Employer Site

Cordis · 1 week ago

Senior Manager, Microbiology

Irvine, CA

Full-time

Onsite

Senior Level, Lead/Staff

$140K/yr - $200K/yr

12+ years exp

Cordis specializes in the development of groundbreaking technology for drug device combination products. The Senior Microbiology Manager provides strategic leadership and technical oversight for microbiological activities supporting the manufacture of drug-eluting balloon combination products, ensuring compliance with regulatory requirements and establishing robust microbiological controls.

Health CareHealth DiagnosticsMedical

No H1B

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

Qualification

MicrobiologySterility assuranceGMPISO 13485FDA QSREU MDREnvironmental monitoringBioburden controlEndotoxin testingSterilization validationRisk managementContinuous improvementLeadershipProblem-solvingCommunication skills