Scientist, QC Raw Materials - Method Transfer & Validation

Fujifilm • Holly Springs, NC

2d • Onsite

About The Position

We are looking for a scientist with experience with raw materials and specific primary packaging for drug product manufacturing. We are looking for a structured, pragmatic and diplomatic person that can support the drug product area within QC Raw Materials. You will be working closely with the small team handling materials to enable the readiness of the drug product facility. Additionally, you will be involved in tech transfers for new customers and their products at FUJIFILM Biotechnologies.

Requirements

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

Nice To Haves

• Preferable experience from similar role.
• 2+ years of experience with customer meetings and audit/inspections.
• 5+ years of experience in a GMP environment.
• Experience with Microsoft Office, Smartsheet, LIMS and ERP systems (e.g., SAP).

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.
• Focus on continuous improvements to all our processes and challenge status quo.
• Performs other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level