Microbiology QC Supervisor
2 weeks ago
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location / Division Specific Information
Role is onsite based in San Francisco, CA and will support our Cell Therapy (CTx) business unit of Thermo Fisher Scientific. At CTx San Francisco, we accelerate advanced cell therapies for difficult to treat conditions, including cancer, rare diseases, and other illnesses, from a newly opened cGMP manufacturing facility. In this facility, Thermo Fisher Scientific offers customers, process and analytical development capabilities, as well as clinical and commercial manufacturing services, for advanced therapies derived from either a patient’s cells or from a donor source.
What will you do?
Perform all supervisory functions within the QC Microbiology laboratory to ensure site compliance with cGMP testing and corporate requirements reporting to the QC Manager Provide leadership to assigned staff by developing and empowering QC Micro team while putting them in a position to succeed by meeting their personal career and organizational goals. Build effective teams that apply their diverse skills and perspectives to achieve common goals, drive engagement and create a climate where staff are motivated to do their best. Overall coordination of work schedules for their team and be accountable for daily activities of the microbiological laboratory to ensure appropriate quality output. Ensure testing is performed in an accurate and timely manner to meet production schedule and project timelines including, but not limited to, microbial limits, routine EM, sterility, growth promotion, etc. for facility readiness, raw materials, in-process, formulated drug product. Deliver analytical solutions to clients through expertise in Microbiological-specific method qualification and validation strategies. Oversee the group’s activities of testing for incoming raw materials, facility environmental monitoring, in-process, and formulated Drug Product. Revise/review specifications, SOPs, and other documents regarding QC Micro Lab Train new hires on department processes, procedures and tools. Leads investigations and provides resolution to test method issues and any quality events ( deviations/OOS/OOT) arising from QC Micro laboratory operation and activities. Interact with auditors/clients during visits and tours. Responsible for microbial method validation/verification ensuring the test methods are fit for their intended purpose and aligned with regulatory and company requirements. Review and approval of documentation and data generated by the group. Communicate articulately with colleagues within manufacturing, engineering, AD/PD and QC staff, to resolve technical issues and direct activities. Support cross-functional teams (MFG/MSAT) to develop contamination control strategy and aseptic process manufacturing control. Provide support to site Safety initiatives. Other job duties as assigned.How will you get here?
Education:
Minimum required education: Bachelor's degree in science, preferably Microbiology or Biology, or related field.Experience:
5 years of industry experience in a cGMP-regulated lab environment. Minimum of 2 years direct people leadership experience. Knowledge of QC chemistry techniques is required, with experience with cGMP laboratory environment. Cell therapy experience required. CDMO background preferred. Experience performing environmental monitoring preferred.Knowledge, Skills, and Abilities:
Ability to drive functional, technical and operational excellence. Firm knowledge of cGMP regulations. Technical expertise with compendial and specific QC microbiology methodologies Good interpersonal and communications skills; written and oral. Proven understanding of applicable regulatory requirements as it relates to analytical method transfer, microbial verification, ICH, USP etc. Demonstration of logical approach to solving scientific problems.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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Microbiology QC Supervisor
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San Francisco, United States Thermo Fisher Scientific, Inc. Full timeAs part of the Thermo Fisher Scientific team, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cl Microbiology, Microbiology, Biology, QC, Supervisor, QC Manager
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