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 TechTransfer Activities the candidate will be responsible for performing inprocess release and stability testing using the established analytical methods.

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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.

College Station Texas may be a small university town but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile radius so we are in the center of it all in Texas. And our site is nestled in the hub of innovation representing a source of pride for the area.

Reports to QC Manager Chemistry

Work Location College Station TX

Primary Responsibilities:

• Perform QC analytical testing for GMP inprocess release and stability testing as needed:
  • PH Conductivity & qPCR required.
  • HPLC RPHPLC 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 RPHPLC 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:

• Bachelors degree in Chemistry Biochemistry or related degree with three 3 years handson laboratory experience; OR
• Associates degree in Chemistry Biochemistry or related degree with five 5 years of handson 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:

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 handeye 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.

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 viaemail 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.

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