Senior Manager, QC Microbiology CAR T (Wednesday - Saturday)
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The Sr. 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 for 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 Sr. Manager, QC Microbiology is responsible for acting as the SME during regulatory inspections.
Management and coordination of the Microbiological Laboratory testing program and schedule 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.
Ensure that all materials, products, methods, and equipment are within specifications and the accurate and timely disposition of test results and compliance investigations.
Ensure that Microbiology lab test results that 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.
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 the career development of direct reports.
Knowledge, Skills, and Abilities:
Advanced knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines as related to the manufacturing 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, 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 timelines.
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.
Seven years of Quality work experience
Demonstrated work experience in a GMP environment
Three years of managerial experience
Demonstrated experience in supporting sterile and or aseptic manufacturing operations.
Experience in participating in and supporting regulatory audits
Experience in working with Quality Systems such as SOPs, Change Control, Deviations, CAPAs, and Risk Assessments
An equivalent combination of education of experience may substitute
Bachelor’s degree in Microbiology or Advanced Degree
Seven7 years’ Quality work experience in a Microbiology laboratory and/or Environmental Monitoring setting
Experience working with cell therapy products
Experience in participating in and supporting FDA, MHRA, PMDA, etc. audits
Working Conductions: (US Only):
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.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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