Sr Analyst 1, QC Microbiology

Position Overview

The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Analyst 1, QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures. This role primarily works independently with minimal supervision as needed, consults with management on key decisions.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

Job Description

About This Role

• Executes advanced lab testing and support for all laboratory assays for all samples, and acts as a Subject Matter Expert (SME) and qualified trainer of at least one test
• Leads sample collection and manages sample logistics for testing
• Supports testing for all qualification and study directed testing
• Supports investigation of routine OOS assays and events
• Conducts qualification and validation protocols
• Leads sterility testing
• Reviews intermediate lab testing results
• Troubleshoots complex assays
• Writes and assists with document preparation and review
• Manages project timelines
• Assists management with training and on-boarding of new staff as needed
• 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

• Bachelor's with 2+ years of relevant Microbiology experience OR
• Master's with 0 years of experience • Experience with aseptic production & support
• 1-3 years in a GMP environment • 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 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

• Master's with 1+ years of experience
• 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 troubleshoot complex equipment and instrumentation (MALDI, MicroSeq)
• Advanced LIMS / Trackwise software training
• Experience working within a QC laboratory environment, commissioning Pharmaceutical and/or laboratory facilities

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

PHYSICAL REQUIREMENTS PHYSICAL DEMANDS

Will work in environment which may necessitate respiratory protection X No Yes

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes

Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes

Ability to discern audible cues. No X Yes

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes

WORKING ENVIRONMENT PHYSICAL DEMANDS

Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes

Ability to stand for prolonged periods of time. No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)

Ability to sit for prolonged periods of time. No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes

Ability to operate machinery and/or power tools. X No Yes

Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.

Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. No X Yes

ENVIRONMENTAL CONDITIONS

Will work in warm/cold environments X No Yes Range (If yes, specify approximate temperature ranges.)

Will work in outdoor elements such as precipitation and wind. X No Yes

Will work in small and/or enclosed spaces. No X Yes

Will work in heights greater than 4 feet. No X Yes

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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 [email protected].

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 Information

Fujifilm 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 Information

If 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 ([email protected]).