QC Raw Materials Scientist-Primary Packaging Transfer

Merck & Co.; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, North Carolina is seeking a scientist with hands-on experience in raw materials and primary packaging for drug product manufacturing to support the QC Raw Materials group and readiness of the DP facility. You will contribute to tech transfers for new customers and their products at FUJIFILM Biotechnologies.

You will collaborate with a small team to enable drug product readiness, author testing strategies and SOPs, and interact with customers during tech

Qualifications

• Master's degree in Life Sciences or Engineering with GMP QA experience.
• Experience in GMP environment and pharmaceutical quality systems.
• Experience with regulatory requirements for materials (cGMPs, USP, EP, JP, ICH).

Responsibilities

• Author testing strategies, specifications for primary packaging materials and raw materials used in DP manufacturing.
• Write and update SOPs within DS and DP material areas.
• Represent QC Raw Materials in Tech Transfer projects and customer interactions.

Skills

Regulatory knowledge

Quality control

Regulatory interpretation

Technical writing

Stakeholder management

Education

Master's degree in Life Sciences or Engineering

Tools

Microsoft Office

Smartsheet

LIMS

SAP ERP

Job description

FUJIFILM Biotechnologies in Holly Springs, North Carolina is seeking a scientist with hands-on experience in raw materials and primary packaging for drug product manufacturing to support the QC Raw Materials group and readiness of the DP facility. You will contribute to tech transfers for new customers and their products at FUJIFILM Biotechnologies.

You will collaborate with a small team to enable drug product readiness, author testing strategies and SOPs, and interact with customers during tech