Sr. Analyst 1, QC Chemistry (Routine Testing)

Fujifilm

  • Holly Springs, NC
  • Permanent
  • Full-time
  • 1 month ago
Position OverviewThe QC Chemistry Sr. Analyst 1 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 QC Chemistry Sr. Analyst 1 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 role 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. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.Company OverviewFUJIFILM 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:Job DescriptionWhat You'll Do
  • 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 Diosynth Biotechnologies objectives.
  • Performs other duties, as assigned
Minimum Requirements:
  • B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of 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-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.
Preferred Requirements:
  • M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 1+ years of experience
  • Familiar with Raw Material methodology as it pertains to cGMP
  • Experience with LIMS software
Physical and Work Environment Requirements: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 minutesAbility to sit for prolonged periods of time up to 240 minutesAbility to conduct activities using repetitive motions that include writs, hands and/or fingers.Ability to conduct work that includes moving objects up to 10 pounds.Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.Will work in warm/cold environmentsWill work in small and/or enclosed spaces.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 via-email, 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.EEO InformationFujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.ADA InformationIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).

Fujifilm