QC Chemist III

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.

The work we do at FUJIFILM Diosynth Biotechnologies 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 create 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 FUJIFILM Diosynth Biotechnologies call Genki.

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 Genki.

Physical Requirements:

• 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 30 pounds on occasion.
• Attendance is mandatory.