QC Chemist III - Night Shift

Position Overview

The Quality Control Chemist III, with limited supervision, will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.  Following Tech-Transfer Activities, the candidate will be responsible for performing in-process, release and stability testing using the established analytical methods.

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

Job Description

Reports to                QC Manager, Chemistry

Work Location         College Station, TX 

 

Primary Responsibilities:

• Perform QC analytical testing for GMP in-process, release and stability testing as needed:
  • PH Conductivity & qPCR required.
  • HPLC, RP-HPLC, SEC, Agarose Gel Electrophoresis, UPLC, CE, IEF, Protein Purity Assay, Peptide Mapping, DNA Sequencing and/or UV/Vis Spectrometry preferred.
  • Residual Analysis and/or Surfactant Analysis
  • Osmolality testing
• Executes technical transfer, qualification and validation protocols as needed.
• Technical Writing to include:
  • Writes and revises Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
  • Qualification protocols
  • Transfer Protocols
  • Creating manuals for processes/activities
  • Sample plans (support & edit)
  • Assisting and initiating closure of deviations, CAPAs and Change Controls
  • Reviewing Methods for accuracy:
    • HPLC, Chromatography (Ion Exchange, SEC, RP-HPLC, Residual Analytes)
• Assist with technical training of less experienced members of the team.
• Facilitate the maintenance and repair of equipment.
• Develop and support a system for managing test samples, reagents and reference standards.
• Reviews data obtained for compliance to specifications and reports excursion/out of specifications.
• Provides OOS investigational support as needed.
• Provides QC support for the sites Environmental Monitoring program and raw material analysis.
• Perform other duties as assigned.

 

Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, or related degree with three (3) years hands-on laboratory experience; OR
• Associates degree in Chemistry, Biochemistry, or related degree with five (5) years of hands-on laboratory experience;
• AND 2 years’ industry experience in a GMP / GxP or a comparable federally regulated environment.
• Familiar with monoclonal antibody testing methodology preferred.
• Experience in assay troubleshooting and problem solving preferred.
• Ability to analyze raw data, assess assay and system suitability criteria, understand process from beginning to end, and explain process.
• Excellent communication skills.
• Ability to work independently or in a team.
• Perform as a SME in the designated methods transferred into FDBT.
• Previous pipetting experience.
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Utilize MSDS 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