Senior Analyst 1, Quality Control Bioassay

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, 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:

Job 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 CAPA's
• 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 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.

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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 (View email address on hirelifescience.com).