The Sr. Manager, Quality Control (Microbiology) is responsible for the effective management of the Quality Control Microbiology team to assure on time analysis of manufactured product and environmental monitoring samples. Responsible to assure all testing is performed in compliance with applicable regulations, company specifications, procedures, and policies at Fujifilm Diosynth Biotechnologies.
The Sr. Manager, Quality Control (Microbiology) is the site SME for Microbiology, with oversight of microbial and environmental control in the manufacturing facility. The roles plays a key partnership with manufacturing operations through trend identification, best practice establishment and continual improvement of operations.
The Sr. Manager, Quality Control (Microbiology) is key to creating an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross-functionally to deliver exceptional results and ensure long-term business success. This role is essential to the success of the wider QC function, working in collaboration with peers to deliver the wider QC strategic plan.
Main areas of responsibility include, but are not limited to:
The Sr. Manager, Quality Control (Microbiology) may supervise 10 or more exempt or non-exempt staff. They contribute to the development of the capital and expense budget and have approval authorities as defined in the company's authorization matrix. They are responsible for managing the department activities in a manner that meets or exceeds the company objectives regarding revenue, profit plan, supply, and compliance.
Minimum Education Requirements
BSc, in Microbiology or related technical field
Knowledge and experience of Bioburden, endotoxin and EM testing
Desired Experience
10+ years related experience (6 years required with relevant MS or PhD degree) in GMP laboratory environment including 5 years supervisory experience
Experience working in a lean manufacturing or six sigma environments
Experience with LIMS and other data management systems
Specific Skills and Competencies
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
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