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Senior Analyst 1, Quality Control Bioassay

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 18 June 2026 (30+ days ago)

Application Deadline: 15 September 2026

Vacancies: 1 Vacancy

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Department:

Quality Control

Job Summary

Position Overview

The Senior Analyst 1 Quality Control Bioassay works with limited direction to execute QC cell- and plate-based analytical methods including protein binding assays cell-based potency assays cell culture routine maintenance and residual testing for DNA Host Cell Protein (HCP) Protein A/G.

The QC Bioassay Sr. Analyst 1 adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identify laboratory exceptions invalid assays deviations change controls and corrective and preventative actions (CAPAs). The Sr. Analyst 1 QC Bioassay 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 Bioassay laboratory associates.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

Responsibilities:

Executes cell- and plate-based analytical methods including protein binding assays (e.g. ELISA Dot Blot etc.) cell-based potency assays cell culture maintenance and residual testing for DNA Host Cell Protein (HCP) Protein A/G
Ensures analytical testing of in process drug substance (DS) drug product (DP) and stability samples are 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 Bioassay
Identifies and follows-up on excursions and deviations and initiate corrective and preventative actions (CAPAs)
Coordinates and supports QC Bioassay lab activities as needed
Provides training for QC Bioassay lab associates
Supports laboratory execution of analytical method transfers and validations
Assists with authoring and reviewing 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

Requirements:

Knowledge and experience growing and maintaining mammalian cell lines
Knowledge of cGMPs ICH USP EP JP and FDA requirements as it relates to Bioassay analytical methods
Working knowledge and experience in Microsoft Office products (Outlook Word Excel and Power Point)
Ability to work with minimal supervision Ability to effectively communicate and function in a fast-paced highly technical environment is essential to success
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
Excellent verbal and written communication skills and attention to detail
Thorough understanding of pharmaceutical/biotech testing
Proven ability to conduct investigations writing deviations and CAPAs
Superior technical writing and problem-solving skills required
Must be flexible to support 24/7 manufacturing facility

Education/Experience Requirements:

B.S. in Microbiology Virology Biology Chemistry Biochemistry Biological Sciences or related science field with 2 years of experience
M.S. in Virology Microbiology Biology Chemistry Biochemistry Biological Sciences or related science field with 0 years of experience
3 years laboratory experience
1-3 years GMP laboratory experience
Experience with cellular and molecular analytical testing methods
Experience performing QC testing involving cell culture PCR ELISA Dot Blots etc

Preferred Education/Experience:

M.S. in Virology Microbiology Biology Chemistry Biochemistry Biological Sciences or related science field with 1 years of experience
Experience with LIMS software

Physical Requirement:

Ability to discern audible cues.
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 writs hands and/or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.

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 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 Information

Fujifilm is committedto 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 ().

Required Experience:

Senior IC

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About Company

Fujifilm

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