Analyst QC Bioassay

Position Overview

The QC Analyst, Bioassay, with direction from manager, executes 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 Analyst, Bioassay 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 QC Analyst, Bioassay is primarily responsible for executing routine analytical methods in support of manufacturing, and as needed supporting laboratory execution of analytical method transfers and validations.

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 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.

Knowledge, Skills, and Abilities

• Ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.
• 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 moderate supervision.
• 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 assist with conducting investigations, writing deviations and CAPAs.
• Basic technical writing and problem-solving skills required.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• Bachelor’s degree in life sciences, Virology, Biology, Chemistry, Biochemistry or related science field with 0-1 years of experience.
• Basic understanding of GMP, GLP, GDP requirements.
• Experience with cellular and molecular analytical testing methods.
• Experience performing QC testing involving cell culture, PCR, ELISA, Dot Blots, etc.

Preferred Qualifications

• 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 stand for prolonged periods of time for up to 240 minutes.
• Ability to sit for prolonged periods of time for up to 240 minutes.
• 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 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 ([email protected]).