Scientist, QC Raw Materials - Method Transfer & Validation

About the role

We are looking for a scientist with experience in raw materials and specific primary packaging for drug product manufacturing. This position involves supporting the drug product area within QC Raw Materials, working closely with a small team handling materials to ensure the readiness of the drug product facility. Additionally, you will be involved in tech transfers for new customers and their products at FUJIFILM Biotechnologies.

Responsibilities

• Authoring testing strategies, specification justifications and corresponding specifications for primary packaging materials, disposables and raw materials used in the DP manufacturing processes and any devices to be used together with the product.
• Writing and updating SOPs within the DS and DP material area.
• Representing QC Raw Materials in Tech Transfer projects, including customer interactions.
• Focusing on continuous improvements to all our processes and challenging the status quo.
• Performing other duties as assigned.

Requirements

• Master’s degree in Life Sciences or Engineering and 4+ years of experience in GMP quality assurance and/or similar role.
• 5+ years of experience within the pharmaceutical industry, preferably within the field of starting materials and primary packaging.

Qualifications

• Advanced knowledge of regulatory requirements for materials (e.g., cGMPs, USP, EP, JP, and ICH).
• Broad knowledge of quality control operations, systems, and directives.
• Excellent technical writing skills, and clear oral and written presentation abilities.
• Strong stakeholder management and communication skills, enabling alignment across sites and global functions.

Skills

• Displays an advanced knowledge of regulatory requirements for materials (e.g., cGMPs, USP, EP, JP, and ICH).
• Possesses a broad knowledge of quality control operations, systems, and directives.
• Ability to challenge and interpret regulations with scientific confidence and sound risk-based judgement.
• Demonstrates excellent technical writing skills, and clear oral and written presentation abilities.
• Strong stakeholder management and communication skills, enabling alignment across sites and global functions.

Benefits

Company Overview: FUJIFILM 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 a culture that fuels your purpose, energy, and drive—what we call Genki.

Pay

Competitive salary based on qualifications and experience.

Schedule

Full-time, Monday through Friday, 8:00 AM to 4:30 PM.

Location

Holly Springs, North Carolina.

Contact

To apply, please visit: https://www.fujifilm.com/us/en/about/region/careers