Website Fujifilm
Fujifilm
Company : Fujifilm
Position Overview:
The QC Analyst II, Cell Biology will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Company Overview:
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:
Job Description:
Reports to QC Supervisor/Manager, Cell Biology
Work Location College Station, TX
Primary Responsibilities:
Participate in training the QC Bioassay Staff at FDBT in the established release methods.
Perform QC analytical testing for GMP release and stability testing as needed.
Perform ELISA based methods, cell-based assays and qualification of critical reagents methodologies.
Execute tech transfer, qualification, and validation protocols as needed.
Contribute to writing and revising Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
Support the establishment of a system for managing test samples, reagents and reference standards.
Report excursion/out-of-specification results to QC Departmental management.
Assist in the preparation of technical proposals, amendments, reports and memoranda.
Provides OOS investigational support as needed.
Perform other duties as assigned.
Qualifications:
Bachelor’s degree preferably in Biology or Biochemistry with 2+ years of relevant laboratory experience; OR
Associate’s degree preferably in Biology or Biochemistry with 3+ years of relevant laboratory experience.
AND 1+ year of experience in a GLP/GxP or a comparable federally regulated environment required.
Familiar with monoclonal antibody testing methodology.
Experience in assay troubleshooting and problem solving.
Familiar with Quality Systems.
Proficient in ELISA based methods, cell-based assays and qualification of critical reagents methodologies.
Ability to analyze raw data, assess assay and system suitability criteria.
Perform as a SME in the designated methods transferred into FDBT from FDBU.
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.
Excellent attention to detail.
Computer proficiency required.
Excellent written and oral communication skills.
Excellent 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 wear personal protective equipment including safety glasses, lab coat, and gloves.
Ability to lift up to 15 lbs regularly and up to 30 lbs on occasion.
Attendance is mandatory.
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 ((url removed) or (phone number removed)).