Senior Analyst , QC Analytical Development - Bioassay

Senior Analyst 1, QC Analytical Development - Bioassay

This role is for a Senior Analyst 1, QC Analytical Development - Bioassay, based in Holly Springs, North Carolina. The contract length is unspecified, with a pay rate of "unknown". Key skills include GMP compliance, analytical method validation, and QC Bioassay testing. A Bachelor’s or Master’s degree in a related science field and 2+ years of experience in a GMP environment are required.

Location:

Holly Springs, NC, United States. On-site.

Fujifilm Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the 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.”

• Executes analytical method transfers and validations for plate and cell‑based Bioassays for the QC Analytical Development team.
• Ensures compliance of analytical testing with appropriate GMP regulations.
• Participates in regular meetings for TT programs with cross‑functional teams and key stakeholders.
• Authors and reviews SOPs, protocols, and technical reports.
• Works cross‑functionally with Contract Laboratory Organizations (CLOs), QC testing teams, Quality Assurance (QA), and Process Science groups to ensure transfer of methods according to deadlines.
• Collaborates with the LIMS team and IT department to build new analytical method functionality that meets end‑user and customer requirements.
• Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.).
• Supports regulatory requests and inspections.
• Supports the QCAD team to investigate any project challenges with necessary risk assessment tools and techniques, as needed.
• Supports best practices for TT and PPQ strategies globally, as required.
• Coordinates and supports QCAD Bioassay lab activities and provides training for QC Bioassay lab technicians.
• Performs other duties, as assigned.

• Bachelor’s Degree in Microbiology, Virology, Biology, Biological Sciences, Engineering, or related science field with 2+ years of analytical laboratory experience preferably in Biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO).
• Master’s Degree in Virology, Microbiology, Biology, or related science field with 0+ years of previous experience.
• 1+ years of experience in a GMP environment.
• Experience with QC Bioassay testing methods including protein binding assays (e.g. ELISA, Dot Blot, etc.).
• Experience with analytical method development, tech transfers and validation residual testing for DNA, Host Cell Protein (HCP), Protein
  
  A.

• Master’s in Virology, Microbiology, Biology or related science field with 1+ years of related experience.
• Experience with LIMS software.

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time up to 60 minutes.
• Ability to sit for prolonged periods of time up to 60 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.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• Will work in small and/or enclosed spaces.
• Will work in heights greater than 4 feet.

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.