Analyst 1, QC Chemistry

Fujifilm • Holly Springs, NC

8d • Onsite

About The Position

Position Overview The Analyst 1, QC Chemistry works with direction to execute QC Analytical Chemistry methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Analyst 1, QC Chemistry, adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines and standard operating procedures. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations. The Analyst 1, QC Chemistry is primarily responsible for executing routine analytical methods in support of manufacturing. Company Overview The work we do at FUJIFILM 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 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 What You’ll Do Executes physical and chemical analytical testing methods used in biological product manufacturing, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (UV, UV-Vis), electrophoresis (non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. Ensures analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to standard operating procedures. Ensures analytical testing data is captured in LIMS software and data integrity is maintained. Reports assay performance and assists with implementing improvements that ensure quality and efficiency within QC Chemistry. Identifies excursions and deviations. Coordinates and supports QC Chemistry lab activities as needed. Works cross-functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objectives. Performs other duties, as assigned.

Requirements

• Bachelor’s Degree in Chemistry, Biochemistry, Biological Sciences, or related science field with 1- 3 years relevant experience.
• 1+ years laboratory experience.
• 1-3 years GMP laboratory experience.
• Experience with physical and chemical analytical testing methods used in biological product manufacturing including spectroscopy (UV, UV-Vis, FTIR), wet chemistry, and physical appearance.
• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time up to 240 minutes.
• Ability to sit for prolonged periods of time up to 240 minutes.
• Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, and reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• Will work in warm/cold environments.
• Will work in small and/or enclosed spaces.

Nice To Haves

• Experience with physical and chemical analytical testing methods used in biological product manufacturing including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (UV, UV-Vis, FTIR), electrophoresis (non-reducing and reducing CESDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. with cellular and molecular analytical testing methods
• Experience with LIMS software.

Responsibilities

• Executes physical and chemical analytical testing methods used in biological product manufacturing, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (UV, UV-Vis), electrophoresis (non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc.
• Ensures analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to standard operating procedures.
• Ensures analytical testing data is captured in LIMS software and data integrity is maintained.
• Reports assay performance and assists with implementing improvements that ensure quality and efficiency within QC Chemistry.
• Identifies excursions and deviations.
• Coordinates and supports QC Chemistry lab activities as needed.
• Works cross-functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objectives.
• Performs other duties, as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees