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FUJIFILM Biotechnologies · 1 day ago

Analyst, Quality Control Bioassay

Holly Springs, NC

Full-time

Onsite

New Grad, Entry Level

0+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Quality Control Bioassay Analyst is responsible for executing QC cell- and plate-based analytical methods, ensuring compliance with GMP regulations, and coordinating lab activities to support manufacturing processes.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

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

Supports laboratory execution of analytical method transfers and validations

Assists with authoring and reviewing QC SOPs

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

Qualification

GMP laboratory experienceCell-based potency assaysProtein binding assaysLIMS softwareCommunication skills

Required

Bachelor's degree in life sciences, Virology, Biology, Chemistry, Biochemistry or related science field with 0 - 2 years of experience

0-2 years GMP laboratory experience

Preferred

Experience with LIMS software

Company

FUJIFILM Biotechnologies

Glassdoor3.4

For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.

Founded in 2011

Morrisville, North Carolina, USA

1001-5000 employees

https://fujifilmbiotechnologies.fujifilm.com/

H1B Sponsorship

FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2021 (1)