Scientist 1, Global QC Analytical Development Raw Materials

Location: Holly Springs
Posted on: June 23, 2025

Job Description:

FUJIFILM Diosynth 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. What Youll Do • Serves as a subject matter expert (SME) in cross-functional teams to assess testing approaches, determine internal and external laboratory verification and validation needs, and provide technical support for troubleshooting new material testing investigations • Represents Global QC Analytical Development on internal and external tech transfer meetings related to the introduction of new materials for the manufacture of biological drug substances and drug products • Engages with customers about customer controlled and Fujifilm Diosynth Biotechnologies controlled materials • Creates overviews, tracks and manages activities for raw material implementation (test strategy, test site, method transfer plan), providing clear timelines and progress updates to stakeholders • Performs change control assessment activities for tech transfers, including handling changes from customers on customer-controlled materials, and onboarding new and generic raw materials, consumables, test laboratories, and specifications • Transfers analytical methods for testing and disposition of incoming raw materials and components according to specifications and procedures • Develops plans and monitors progress for incoming and ongoing change controls for program items and vendor change notifications • Authors, reviews, and approves analytical method transfer plans, documents and reports (specification justification reports (SJRs) and transfer summary reports (TSRs) for compendial and non-compendial methods, and change control assessments to support tech transfer activities • Provides RM testing compendial method oversight and ensure compliance with GMP guidelines, e.g. ICH, EMA, FDA, etc. • Supports and participates in regulatory audits and client inspections • Leads cross-functional collaboration with QC Analytical Development, QC Program Management, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives • Provides technical expertise on investigations for Out of Specification (OOS) results • Provides support and guidance to internal QC stakeholders • Performs other duties as assigned Minimum Requirements: • Bachelor’s Master’s in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 5 years’ experience OR • Master’s in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 3 years’ experience OR • PhD with 1 years of applicable industry experience • 4-6 years of experience in a federally regulated GMP environment • 4 years’ experience in a GMP environment • Experience with method transfers Preferred Requirements: • In-depth knowledge of Raw Material methodology as it pertains to cGMP • Experience in assay troubleshooting and problem solving Physical and Work Environment Requirements: • Ability to discern audible cues. • Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. • 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 wrists, 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 warm/cold environments (5 C) • Will work in small and/or enclosed spaces.

Keywords: , Greensboro , Scientist 1, Global QC Analytical Development Raw Materials, Manufacturing , Holly Springs, North Carolina