Analyst, QC Bioassay

Fujifilm•Holly Springs, NC

11h•Onsite

About The Position

The QC Analyst, Bioassay executes routine cell- and plate-based analytical methods under the direction of a manager, including protein-binding assays, cell-based potency assays, cell culture maintenance, and residual testing for DNA, Host Cell Protein (HCP), and Protein A/G. The role follows GMP-compliant laboratory operations and regulatory guidelines, generates analytical results, and identifies laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). It primarily supports manufacturing and may also support analytical method transfers and validations. The analyst tests in-process, drug substance, drug product, and stability samples; records results in LIMS while maintaining data integrity; reports assay performance; and helps improve quality and efficiency in QC Bioassay. The role also supports laboratory activities, contributes to QC SOP authoring and review, and collaborates with QC departments, Manufacturing, Process Science, and Quality Assurance. The position is at FUJIFILM Biotechnologies’ facility in Holly Springs, North Carolina, and requires flexibility to support a 24/7 manufacturing facility.

Requirements

Bachelor’s degree in life sciences, Virology, Biology, Chemistry, Biochemistry, or a related science field.
0–1 years of experience.
Basic understanding of GMP, GLP, and GDP requirements.
Experience with cellular and molecular analytical testing methods.
Experience performing QC testing involving cell culture, PCR, ELISA, Dot Blots, or similar methods.
Knowledge and experience growing and maintaining mammalian cell lines.
Knowledge of cGMPs, ICH, USP, EP, JP, and FDA requirements as they relate to bioassay analytical methods.
Working knowledge and experience with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
Ability to work with moderate supervision and function effectively in a fast-paced, highly technical environment.
Demonstrated ability to work cross-functionally and develop and maintain strong business partner relationships.
Excellent verbal and written communication skills and attention to detail.
Thorough understanding of pharmaceutical/biotech testing.
Ability to assist with conducting investigations and writing deviations and CAPAs.
Basic technical writing and problem-solving skills.
Flexibility to support a 24/7 manufacturing facility.

Nice To Haves

Experience with LIMS software.

Responsibilities

Execute cell- and plate-based analytical methods, including protein-binding assays such as ELISA and Dot Blot, cell-based potency assays, cell culture maintenance, and residual testing for DNA, HCP, and Protein A/G.
Perform analytical testing of in-process, drug substance, drug product, and stability samples in accordance with applicable GMP regulations.
Capture analytical testing data in LIMS software and maintain data integrity.
Report assay performance and assist with implementing improvements to quality and efficiency within QC Bioassay.
Identify and follow up on excursions and deviations, and initiate corrective and preventative actions (CAPAs).
Coordinate and support QC Bioassay laboratory activities as needed.
Support laboratory execution of analytical method transfers and validations.
Assist with authoring and reviewing QC SOPs.
Work cross-functionally with QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders.
Perform other duties as assigned.