Senior Analyst 1, QC Chemistry

FUJIFILM; Holly Springs (AL); On-site; USD 75,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Analyst 1, QC Chemistry to execute analytical methods for biological products and to ensure GMP-compliant lab operations. The role includes method validation support, CAPA handling, training, and cross-functional collaboration across QC, Manufacturing, and QA teams.

The ideal candidate will have a 3+ year lab background in chemistry/biochemistry, GMP experience, and hands-on experience with chromatography, spectroscopy,

Qualifications

• Bachelor’s Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience.
• 3+ years laboratory experience.
• 1-3 years GMP laboratory experience.
• Experience with physical and chemical analytical testing methods including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc., with cellular and molecular testing methods.

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 CESDS, icIEF), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc.
• Ensures analytical testing of in-process, DS, DP, and stability samples is performed according to GMP regulations.
• Ensures analytical testing data is captured in LIMS software and data integrity is maintained.
• Reports assay performance and assists with improvements that ensure quality and efficiency within QC Chemistry.
• Identifies and follows up on excursions and deviations and initiates 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 objectives.
• Performs other duties, as assigned.

Skills

GMP experience

Laboratory analytics

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field

Master’s Degree (preferred)

Tools

LIMS software

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:

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 essential functions. While performing the duties of this job, the employee is required on a regular basis to:

• 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.

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.

*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]).