The QC Microbiology Lead Associate 2 is a position that supports a broad range of microbiological disciplines and manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory. This is first shift ( Sunday- Wed 7am-5pm) The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with little to no supervision. They are expected to follow procedures and have mastery of a variety of microbiological methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. Microbiological disciplines common to the laboratory include but are not limited to aseptic technique, environmental and clean utility monitoring, bioburden and endotoxin determination, Gram staining, non-host (culture purity) testing, stock culture preparation and maintenance, cell culture maintenance, and associated viral titer assays. The position primarily works independently taking direction from their manager or senior department staff, meanwhile providing direction to junior analysts and peers within the department. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts.
Incumbents in this role will have primary assigned responsibility for Environmental Monitoring functions or Microbiology support, depending upon department needs and individual capacity.
We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At FUJIFILM Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
Job DescriptionRequired Skills/Education:
BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences microbiology or biological sciences, or related technical fieldHas advanced technique skills and is capable of working beyond established procedures to identify and implement process improvementsFamiliarity with basic statistical tools to analyze data in relation to trend resultsFamiliarity with data management processes such as Trackwise and LIMS or the capability to learn advanced functionalities within the systemsCan manage one or more tasks in a manner that promotes effective schedule adherenceAbility to identify and manage changing priorities in a productive and positive mannerCan communicate effectively with colleagues in the department and cross-functionally, building trust and respectAble to achieve Yellow Belt Certification within the company’s Six Sigma programTechnical writing skills (ability to write basic protocols, deviations, and prepare complex reports with or without a template)Problem-solving and troubleshooting competenciesAble to make informed and timely decisions independentlyAbility to contribute beyond own product/department
Desired Skills:
6-8 years related laboratory experience (4 years required with relevant MS degree)Has complete understanding and knowledge of procedures and practices in assigned areaDemonstrated SME and responsible for CAPAs, audit actions, deviations, lab investigations, method revisions, transfers, validations, and qualificationsSupport all necessary laboratory and assay functions, including housekeeping, safety, logbook use and maintenance, equipment use and maintenance, method execution, and data reviewEmbrace lean lab and Six Sigma principles and applies them to laboratory processesNotifies management and initiates events (such as deviations) in the quality systemsPrioritizes and organizes work to deliver assignments according to established schedules and deadlines. May coordinate logistics associated with laboratory testing or supporting documentation with others in the groupTrainer within areas of proficiencyMay have some assigned project responsibilities, such as department representation, document development or review, troubleshooting, and protocol executionContributes to the achievement of team goals and a sense of teamwork within the unit and across the departmentIdentifies and solves problems while informing and consulting with area managementReview and interpret technical data, generate reports and provide recommendations based on statistical data, and identify statistically significant and impactful eventsApplies process improvement methodologies that contribute to solutions to technical issuesRepresents QC department as needed serving as an SME for technical teams and at tier meetingsCan communicate in a manner that fosters cooperation and creates a safe environment for those involved
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.
EEO InformationFujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA InformationIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_FDBU@fujifilm.com).
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