Scientist 1, QC Microbiology (Drug Product & Raw Materials)

Location: Holly Springs
Posted on: June 23, 2025

Job Description:

The Scientist 1, QC Microbiology (Drug Product & Raw Materials) supports a broad range of microbiological functions for both raw materials and drug product manufacturing support. This role manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory in support of these two areas. This role follows procedures and has mastery of a wide variety of microbiological methods specific to raw material and drug product manufacturing and supporting data management processes. The Scientist 1, QC Microbiology (DP and RM) effectively and efficiently manages complex or difficult tasks with expertise within the assigned disciplines. This role initially supports the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments are required. Company Overview 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 • Performs raw material microbial assessments, identifies requirements and executes actions as part of change control process • Performs high throughput, right-first time work to meet production schedules and project milestones with minimal/no supervision • Implements new raw materials, including specification authoring, requesting LIMS builds, assessing changes etc • Supports raw material life cycle management (new material assessment, specification establishment, maintenance of specifications etc.) • Coordinates and is responsible for raw material data review and release for the Microbiology team • Acts as subject matter experts for both raw materials and drug product manufacturing support • Initiates qualification and study directed testing activities in support of Drug Product manufacturing • Initiates technical writing initiatives and promotes problem-solving skills among the team • Reviews and evaluates advanced lab testing results both internally and from third party laboratories • Performs testing and review of QC samples • Serves as point of contact to third party laboratories • Authors, reviews, and edits documents and study protocols • Supports intermediate investigations of OOS assays and events • Ensures compliance with cGMP and participates in audits and inspections • Provides OOS investigational support, as needed • Supports laboratory management and mentors’ others on the team, as needed • Leads LEAN lab and six sigma principles and applies them to laboratory processes • Acts as project leader for projects in the lab and department • Performs other duties, as assigned Minimum Requirements: • Bachelor’s degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 5 years’ experience OR • Master’s degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 3 years’ experience OR • PhD with 1 years of applicable industry experience • 3 years of experience working in a regulated GMP environment • Expert understanding of GMP, GLP, GDP requirements • Experience and proficient knowledge in Microbiology theory • Experience and proficient knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and raw materials testing. • Advanced LIMS experience • Advanced experience with document control including writing and editing technical documents and presentations Preferred Requirements: • SME level knowledge in Microbiology theory • SME level knowledge of Microbiology testing and laboratory experience, specific to both Drug product manufacturing support and raw materials testing

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