Diality
Overview
Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting. Position
The Director of Microbiology is accountable for developing and overseeing the implementation of Microbiology Laboratory Operations. This position will be responsible for designing, developing and conducting microbial method validations, cleaning and disinfection validations, and other microbiological tests. Additional responsibilities include leading the day-to-day operations of the Microbiology Laboratory, setting the direction of the Microbiology Laboratory operations, and developing and overseeing the environmental monitoring program. This position will also oversee and execute the biocompatibility program. Responsibilities
Direct the day-to-day Microbiology testing activities ensuring compliance with cGMP and safety regulations; ensure the microbiology staff are adequately trained and are performing tests per method procedures. Develop in-house capabilities for microbial testing and work with outside laboratories to conduct studies. Accountable for the implementation and lifecycle management of the Contamination Control Strategy. Conduct risk assessments and develop mitigation strategies to minimize risk of contamination, identifying potential sources of contamination and developing strategies to mitigate the risk. Lead the Sterility Assurance program including sterility testing, endotoxin, bioburden testing, cleaning and disinfection validations, testing of utilities and environmental monitoring testing. Provide technical support and subject matter expertise input for manufacturing-related process improvements, change control, deviation investigation, and CAPA implementation. Support problem-solving during testing and for unexpected test results, working collaboratively with all stakeholders and management as needed. Develop and perform aseptic training and an operator qualification program. Support inspection readiness plans and interact with regulatory agencies during inspections on matters related to Contamination Control and Sterility Assurance. Write and execute protocols for demonstrating disinfection adequacy of medical devices. Provide technical guidance for design engineers to ensure device is capable of effectively being reprocessed/sterilized. Operate dialysis machines for the purpose of testing disinfection adequacy Perform basic laboratory tasks such as weighing measuring samples, perform assays, routine equipment operations, calibration and maintenance. Conduct preparation of sterile solutions, evaluation of growth media and laboratory cleaning. Follow all company policies, Federal, State and local regulations and policies for Safety, Health and Environmental compliance. Direct biocompatibility testing to support development and regulatory needs. Translates business segment strategy into functional plans and guides execution. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements. Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization. Reconciles multiple stakeholder views to drive business results. Leads team(s) to solve complex matters and incorporates components, materials, and tools that result in cost-effective and quality output. Required Skills & Abilities
Demonstrated knowledge of cGMP/ICH/FDA/EU compliance regulations and USP and EP monographs for microbiology. Strong familiarity with AAMI/ANSI ST 98, TIR 12, USP Sterility Testing, USP Bacterial Endotoxins. Knowledge of Biosafety level (BSL) requirements and use of risk assessment for the selection of appropriate microbiological practices. Comprehensive knowledge of global GMP regulatory requirements for ISO 17025. Excellent oral and written communication skills with strong technical writing experience. Goal-oriented, organized team player able to prioritize and manage time efficiently. Self-motivated and self-directed. Excellent verbal and written communication skills; must be a listener, a presenter, and a people-person. Ability to create and deploy laboratory procedures. Education & Experience
Bachelor\'s degree in Microbiology, Biology, Biotechnology, Biomedical Engineering, Chemistry, Material Science or related field preferred. 10+ years of relevant experience with medical device manufacturers or a commercial biotechnology or pharmaceutical production environment Travel
Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences. Willingness to travel to Vista, CA for work involving BSL2 requirements (short term). Physical Requirements
Sustained periods of time standing and sitting in a laboratory. Sitting at a desk utilizing a computer. Seniority level
Director Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Diality by 2x Get notified about new Microbiology Manager jobs in Irvine, CA.
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Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting. Position
The Director of Microbiology is accountable for developing and overseeing the implementation of Microbiology Laboratory Operations. This position will be responsible for designing, developing and conducting microbial method validations, cleaning and disinfection validations, and other microbiological tests. Additional responsibilities include leading the day-to-day operations of the Microbiology Laboratory, setting the direction of the Microbiology Laboratory operations, and developing and overseeing the environmental monitoring program. This position will also oversee and execute the biocompatibility program. Responsibilities
Direct the day-to-day Microbiology testing activities ensuring compliance with cGMP and safety regulations; ensure the microbiology staff are adequately trained and are performing tests per method procedures. Develop in-house capabilities for microbial testing and work with outside laboratories to conduct studies. Accountable for the implementation and lifecycle management of the Contamination Control Strategy. Conduct risk assessments and develop mitigation strategies to minimize risk of contamination, identifying potential sources of contamination and developing strategies to mitigate the risk. Lead the Sterility Assurance program including sterility testing, endotoxin, bioburden testing, cleaning and disinfection validations, testing of utilities and environmental monitoring testing. Provide technical support and subject matter expertise input for manufacturing-related process improvements, change control, deviation investigation, and CAPA implementation. Support problem-solving during testing and for unexpected test results, working collaboratively with all stakeholders and management as needed. Develop and perform aseptic training and an operator qualification program. Support inspection readiness plans and interact with regulatory agencies during inspections on matters related to Contamination Control and Sterility Assurance. Write and execute protocols for demonstrating disinfection adequacy of medical devices. Provide technical guidance for design engineers to ensure device is capable of effectively being reprocessed/sterilized. Operate dialysis machines for the purpose of testing disinfection adequacy Perform basic laboratory tasks such as weighing measuring samples, perform assays, routine equipment operations, calibration and maintenance. Conduct preparation of sterile solutions, evaluation of growth media and laboratory cleaning. Follow all company policies, Federal, State and local regulations and policies for Safety, Health and Environmental compliance. Direct biocompatibility testing to support development and regulatory needs. Translates business segment strategy into functional plans and guides execution. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements. Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization. Reconciles multiple stakeholder views to drive business results. Leads team(s) to solve complex matters and incorporates components, materials, and tools that result in cost-effective and quality output. Required Skills & Abilities
Demonstrated knowledge of cGMP/ICH/FDA/EU compliance regulations and USP and EP monographs for microbiology. Strong familiarity with AAMI/ANSI ST 98, TIR 12, USP Sterility Testing, USP Bacterial Endotoxins. Knowledge of Biosafety level (BSL) requirements and use of risk assessment for the selection of appropriate microbiological practices. Comprehensive knowledge of global GMP regulatory requirements for ISO 17025. Excellent oral and written communication skills with strong technical writing experience. Goal-oriented, organized team player able to prioritize and manage time efficiently. Self-motivated and self-directed. Excellent verbal and written communication skills; must be a listener, a presenter, and a people-person. Ability to create and deploy laboratory procedures. Education & Experience
Bachelor\'s degree in Microbiology, Biology, Biotechnology, Biomedical Engineering, Chemistry, Material Science or related field preferred. 10+ years of relevant experience with medical device manufacturers or a commercial biotechnology or pharmaceutical production environment Travel
Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences. Willingness to travel to Vista, CA for work involving BSL2 requirements (short term). Physical Requirements
Sustained periods of time standing and sitting in a laboratory. Sitting at a desk utilizing a computer. Seniority level
Director Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Diality by 2x Get notified about new Microbiology Manager jobs in Irvine, CA.
#J-18808-Ljbffr