$100K — $150K *
The Manager, QC Microbiology, is a highly critical role and is responsible for managing the QC Microbiology Laboratory which provides support to the CAR T manufacturing site. This department is responsible microbiological related testing of in-process samples, final product testing, critical utilities sampling and testing, Validation and requalification support, incoming component testing, and microbiological identification. Sampling and testing must meet or exceed FDA, MHRA, PMDA, EU, and other governmental regulations or guidelines. The Manager QC Microbiology is responsible to act as the SME during regulatory inspections.
Required Competencies: Knowledge, Skills, and Abilities
· Advanced knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as related to manufacture of cell therapy products.
· Advanced data integrity knowledge and practices.
· Intermediate understanding of statistics, control charts, action and alert limits.
· Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.
· Intermediate knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PVs, etc.
· Ability to lead and maintain the development of Microbiology laboratory testing data and trending.
· Advanced verbal and written communication skills.
· Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision- making skills.
· Must be team-oriented and has the demonstrated ability to work cross-departmentally throughout the manufacturing site.
· Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment.
· Advanced mentoring and coaching, influencing, negotiating and personal interaction skills.
· Demonstrated resource management and planning skills. Must be flexible and adaptable, and able to work under pressure, while meeting designated time lines.
· Advanced knowledge of safety, OSHA, and EPA regulations. Electrical and energized equipment
(lockout/tag out), fall safety, HAZCOM, MSDS sheets, etc.
· Advanced of Microsoft Word, Outlook, Excel, PowerPoint, etc.
Duties and Responsibilities
Manage QC Microbiology department
· Management and coordination of the Microbiological Laboratory testing program and scheduling to ensure timely testing and results, to support final product testing and release, incoming components and materials testing and release, and monitoring of the critical utilities systems.
· Development and management of SOPs, forms, and methods required to support the compliant operation and testing conducted in the Microbiology laboratory.
· The Manager, QC Microbiology plays a critical role in ensuring that all materials, products, methods and equipment are within specifications and ensuring accurate and timely disposition of
test results and compliance investigations.
· Ensure that Microbiology lab test results which exceed the specification limits, are submitted as a Deviations in the eQRMS system, investigated, and effective CAPAs are implemented.
· Ensure the site and department objectives are met.
Manage and develop direct reports.
· Management and scheduling of Microbiology laboratory personnel within the department to meet the Manufacturing schedule and needs.
· Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations and support career development of direct reports.
Perform other tasks as assigned.
Education and Experience
· Bachelor’s degree required, preferably in Microbiology or related science.
· Advanced degree preferred.
· 7 years’ relevant Quality work experience required, preferably in a Microbiology laboratory and/or Environmental Monitoring setting. Experience working with cell therapy products is preferred.
· 2-3 years of leadership/managerial experience required.
· Must have experience in supporting sterile compounding and filling operations.
· Experience in participating and supporting regulatory audits preferred: FDA, MHRA, PMDA, etc.
· Experience in working with Quality Systems preferred: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments.
· An equivalent combination of education of experience may substitute.
· The incumbent will be required to work in an office and Microbiology laboratory environment.
· The incumbent will be required to gown for entry into Aseptic core and supporting areas, on an as-needed basis.
· The management incumbent (or designee) will be expected to be on call, to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.
· Occasional travel may be required.
Valid through: 8/6/2020
$100K — $150K
21 days ago