Quality Control - Chemist II

Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: March 20, 2023

Job Description:

Overview Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB) The work we do at FDB 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 FDB call Genki.Summary:The Quality Control Chemist II, 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 release and stability testing using the established analytical methods. External US Essential Functions:

• Perform QC analytical testing for GMP release and stability testing as needed.
  • • pH Conductivity & qPCR required
    • HPLC, Agarose Gel Electrophoresis, UPLC, CE, IEF and/or UV/Vis Spectrometry preferred
    • Osmolality testing
    • SDS Page & Western Blot
      • Executes technical transfer, qualification and validation protocols as needed.
      • Writes and revises Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
      • Develop and support a system for managing test samples, reagents and reference standards.
      • Reports excursion/out of specifications results to the QC Departmental Supervisor/Manager.
      • Provides OOS investigational support as needed.
      • Ensure lab is maintained (organized, clean, properly supplied).
      • Perform other duties as assigned. Required Skills & Abilities:
        • Ability to analyze raw data, assess assay and system suitability criteria.
        • Perform as a SME in the designated methods transferred into FDBT.
        • 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. Working Conditions & 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 30 pounds on occasion.
          • Attendance is mandatory. Minimum Qualifications:
            • Master's degree in Chemistry, Biochemistry or related degree with 1 year hands on laboratory experience; OR
            • Bachelor's degree in Chemistry, Biochemistry or related degree with 2 years hands on laboratory experience.
            • AND 2 years of experience in a GMP/GxP or a comparable federally regulated environment.Preferred Qualifications:
              • Familiar with monoclonal antibody testing methodology. Experience in assay troubleshooting and problem solving. Salary: Starting salary will be commensurate with education and experience. We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail or call .

Keywords: FUJIFILM Holdings America Corporation, College Station , Quality Control - Chemist II, Other , College Station, Texas