Scientist Position at Fujifilm Biotechnologies, USA
FUJIFILM Biotechnologies is hiring a Scientist 1, QC Microbiology in Holly Springs, North Carolina, to support critical microbiological testing for raw materials and drug product manufacturing. This role is part of a rapidly growing Quality Control laboratory supporting the commissioning and operation of North America’s largest end-to-end biopharmaceutical CDMO facility. The Microbiology Jobs at Fujifilm Careers are ideal for experienced GMP microbiology professionals seeking to contribute to life-saving therapies in a state-of-the-art biomanufacturing environment.
Job Details:
- Job Title: Scientist 1, QC Microbiology
- Location: Holly Springs, North Carolina, USA
- Department: Quality Control / Microbiology
- Employment Type: Full-Time
- Industry: Biopharmaceutical Manufacturing / CDMO
- Work Environment: On-site GMP Laboratory
About the Company:
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, NC. By the end of 2025, the company will operate North America’s largest integrated CDMO biopharmaceutical manufacturing facility, providing drug substance production, fill-finish, and packaging under one roof. Part of the global FUJIFILM Group, the organization employs over 70,000 people worldwide and is guided by its purpose of “giving our world more smiles.” FUJIFILM fosters a high-energy, mission-driven culture known as Genki, empowering employees to shape the future of medicine.
Educational Requirements for the Scientist Role:
- Bachelor’s degree in Microbiology, Biochemistry, or related scientific discipline with 5+ years of experience, or
- Master’s degree with 3+ years of relevant experience, or
- PhD with 1+ year of applicable industry experience
- Minimum 3+ years of experience in a regulated GMP environment
Key Responsibilities of the Scientist:
- Perform non-routine and complex microbiological testing for raw materials and drug products
- Support commissioning activities for a new biopharmaceutical manufacturing facility
- Lead qualification studies and study-directed testing activities
- Review, evaluate, and interpret advanced laboratory test results
- Act as a Subject Matter Expert (SME) and qualified trainer for multiple microbiology methods
- Author, review, and edit SOPs, protocols, and technical documentation
- Support investigations related to OOS results and laboratory events
- Ensure compliance with cGMP, GLP, and GDP requirements
- Participate in audits, inspections, and audit readiness activities
- Apply LEAN laboratory and Six Sigma principles to improve lab processes
- Lead laboratory projects and mentor junior team members
- Support laboratory management and continuous improvement initiatives
Skills Required for the Scientist Role:
- Expert knowledge of GMP, GLP, and GDP regulations
- Strong theoretical and practical expertise in Microbiology testing
- Experience with drug product manufacturing support and raw material testing
- Advanced experience using LIMS
- Strong documentation and technical writing skills
- Investigation handling experience (TrackWise or similar systems preferred)
- Ability to manage complex tasks with minimal supervision
- Strong analytical, problem-solving, and decision-making skills
- Effective communication and mentoring abilities
- Familiarity with LEAN, 6S, or Six Sigma methodologies
Benefits of the Microbiology Jobs at Fujifilm Careers:
- Opportunity to work at North America’s largest biopharmaceutical CDMO facility
- Exposure to cutting-edge biologics manufacturing and QC operations
- Career growth within a global life sciences organization
- Collaborative, mission-driven Genki culture
- Work on products that contribute to vaccines, cures, and advanced therapies
- Equal opportunity employer with inclusive hiring practices
- Professional development through leadership, training, and project ownership
