Senior Analyst 1, QC Chemistry

NCBiotech; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC is seeking a Senior Analyst 1, QC Chemistry to execute analytical methods across chromatography, spectroscopy, electrophoresis and other QC testing, ensuring GMP compliant operations. You will generate results, manage CAPAs, support analytical method transfers and validations, and train QC Chemistry staff.

Collaboration with Manufacturing, Process Science and QA is essential, with cross-functional objectives.

Qualifications

• Bachelor's Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field.
• 3+ years of laboratory experience.
• 1-3 years GMP laboratory experience.

Responsibilities

• Execute physical and chemical analytical testing methods used in biological product manufacturing (chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, physical appearance).
• Ensure testing is performed according to GMP regulations and data is captured in LIMS with data integrity.
• Report assay performance and participate in CAPAs and improvements to quality and efficiency in QC Chemistry.

Skills

GMP experience

Analytical chemistry

Laboratory techniques

Education

Bachelor's in Chemistry or related field

Tools

LIMS software

Mass spectrometry

Job description

Position Overview

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

• 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.

Minimum Qualifications

• 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 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

Preferred Qualifications

• 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.

Physical 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 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.

*LI-Onsite

EEO Information

Fujifilm 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 Information

If 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 ([e-mail]).