Analyst, Quality Control Bioassay

Fujifilm•Holly Springs, NC

31d•Onsite

About The Position

The Quality Control Bioassay Analyst works with direction from manager 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 Analyst 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 QC Bioassay Analyst is primarily responsible for executing routine analytical methods in support of manufacturing, and as needed supporting laboratory execution of analytical method transfers and validations. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success. 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

Requirements

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

Nice To Haves

Experience with LIMS software

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