Sr Analyst I, QC Microbiology - Fujifilm

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

About This Role

The QC Microbiology Senior Analyst 1 is responsible for leading the key operational aspects of the QC Microbiology laboratory. Incumbent will perform and train others on the microbial testing of all in -process drug substance, drug product, EM/UM, and raw materials samples.  Incumbent will be responsible for all associated activities associated with this testing in accordance with written procedures. This position primarily works independently with minimal supervision as needed, acting in consultation with management for all decisions. This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory.  Flexibility in job roles and assignments will be required.  This may include writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff as needed and in addition to regular work duties and assignments.

• Performs advanced lab testing and support for all laboratory assays for all samples
• Leads sample collection and manages sample logistics for testing
• Supports testing for all qualification and study directed testing
• Leads sterility testing
• Reviews intermediate lab testing results
• Acts as qualified trainer and SME of at least one test
• Troubleshoots complex assays
• Assists with writing of documents. Reviews and edits documents
• Supports investigation of routine OOS assays and events
• Embraces LEAN lab and six sigma principles and applies them to laboratory processes
• Champions projects and project management as assigned
• Performs other duties, as assigned

Minimum Qualifications

• Bachelors with 2-5 years of relevant Microbiology experience OR
• Masters with 0-3 years of relevant Microbiology experience
• Experience with aseptic production & support
• Advanced understanding of GMP, GLP, GDP requirements
• Advanced knowledge in Microbiology theory
• Advanced knowledge of Microbiology testing and laboratory experience
• LIMS experience
• Experience with document control including reviewing and editing technical documents
• LEAN lab and six sigma six training and/or certification
• Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
• Intermediate LIMS software training
• Knowledge or training of FDA regulations (cGMP, cGLP, cGDP)

Preferred Qualifications

• BS with 5+ years of experience within Microbiology, Biochemistry, Biology
• MS with 3+ years of experience within Microbiology, Biochemistry, Biology
• 4+ years of previous experience working within QC Microbiology or with GXP or quality systems is an advantage
• Advanced experience in a GMP QC Microbiology Laboratory, advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing)
• Advanced experience with microbial ID systems, ability to trouble-shoot complex equipment and instrumentation (MALDI, MicroSeq)
• Advanced LIMS / Trackwise software training
• Experience working within a QC laboratory environment commissioning Pharmaceutical and/or laboratory facilities

FDBN 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 email FDBN_PNC@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.