Senior Analyst 1, QC Chemistry

Fujifilm•Holly Springs, NC

8d•Onsite

About The Position

The Senior Analyst 1, QC Chemistry works with limited 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 Senior Analyst 1, QC Chemistry, adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The Senior Analyst 1, QC Chemistry is primarily responsible for executing routine analytical methods in support of manufacturing, supporting laboratory execution of analytical method transfers and validations, and training other QC Chemistry laboratory associates. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. 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

Requirements

Bachelor's Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience
1- 3 years relevant experience.
3+ years laboratory experience.
1-3 years GMP laboratory experience.
Experience with physical and chemical analytical testing methods used in biological product manufacturing including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE[1]SDS, 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

Nice To Haves

Master's Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field.
1+ years of experience with Raw Material methodology as it pertains to cGMP.
Experience with LIMS software.

Responsibilities

Executes physical and chemical analytical testing methods used in biological product manufacturing, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, 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 appropriate GMP regulations.
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 and follows up on excursions and deviations and initiates corrective and preventative actions (CAPAs).
Coordinates and supports QC Chemistry lab activities as needed.
Provides training for QC Chemistry lab associates.
Authors and reviews SOPs and technical reports.
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.