Sr. Analyst , QC Analytical Development Bioassay

Sr. Analyst 1, QC Analytical Development Bioassay

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The Sr. Analyst 1, QC Analytical Development (QCAD) Bioassay supports the implementation of plate and cell‑based analytical methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies Diosynth Holly Springs (FDBN). This role supports the transfer and validation of methods such as residuals (HCP, DNA, Protein

A), dot blot for product identity, ELISA / Potency and various cell‑based assays. The Sr. Analyst 1, QC AD Bioassay ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and author and review procedures, SOPs, and technical reports.

• 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

• B.S. 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) OR
• M.S. in Virology, Microbiology, Biology, or related science field with 0+ years of previous experience
• 1+ years’ 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 writes, 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.

Mid‑Senior level

Contract

Quality Assurance