The Microbiology IV will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.  This position is a pivotal role to either a technical career path as a Microbiologist IV or a managerial career path as a Lead for the team, and a successful individual in this role will lead the team regardless of the career path they decide to pursue.

Reports to                Supervisor, Microbiology

Work Location         College Station, TX 

The work we do at FUJIFILM Diosynth Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. 

From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If you’re ready to help transform the future of medicine, join FUJIFILM Diosynth Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki. 

Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation.

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: https://www.fujifilm.com/us/en/about/region/careers

Primary Responsibilities:

• Lead the QC microbiological aspects of cGMP compliance and testing.
• Write verification protocols and summary reports as needed for finished product and in process controls and buffers.
• Assist in performing environmental risk assessments for qualification of cleanrooms.
• Serve as SME for the functional streams: utility monitoring, environmental monitoring, and material monitoring.
• In charge of scheduling and managing the training and on-boarding of new staff members and be able to troubleshoot assays when there is a problem encountered.
• Assist in the identification of microbiological root cause analysis and provide technical advice as needed.
• Perform Cost Analysis for methods and monthly metrics of assays performed.
• Lead the investigations and review of alert and action limit investigations as needed and implements corrective action as appropriate.
• Manage the investigations of microbiological data deviations and PRs. 
• Develop and/or contribute toward creating and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices (cGMP) documentation.
• Manage the weekly laboratory schedule of activities for the staff.
• Approval of EM and product release data.
• Manage the plan generation/scheduling in MODA-EM.
• Manage all equipment calibrations/PM events in Blue Mountain.
• Management of inventory for the laboratory and generation of Purchase Orders for supplies.
• Management of CAPAs, Change Controls and Deviations for the group.
• Ensure lab is maintained (organized, clean, properly supplied).
• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree preferably in Biochemistry, Chemistry, Biology, or related field with 4+ years of relevant experience; OR
• Associate of Science preferably in Biochemistry, Chemistry, Biology, or related field with 5+ years of relevant experience; AND
• Proven experience at Level 4/Lead in managing commercial-scale operations and the ability to successfully uphold commercial operations.
• 2+ years in a GMP environment.
• Sound aseptic technique and understanding of industry best practices, techniques, equipment, and materials. 
• Ability to analyze raw data, assess assay and system suitability criteria.
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
• Good attention to detail and ability to utilize problem solving/trouble shooting skills.
• Good computer skills.
• Demonstrated written and oral communication skills.
• Demonstrated leadership skills.
• Strong organization and analytical skills.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
• Ability to lift/pull/push 50 lbs on occasion and 15 lbs regularly.
• Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
• Attendance is mandatory.

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

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.

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.

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 (FDBTHR@fujifilm.com or (979) 431-3500).