QC Raw Materials Scientist: Primary Packaging & Transfer

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a scientist with experience in raw materials and primary packaging for drug product manufacturing. You will support the drug product area within QC Raw Materials and contribute to tech transfers for new customers and their products.

Ideal candidates have GMP QA experience, strong technical writing, and stakeholder management to align with global functions.

Qualifications

• Master’s degree in Life Sciences or Engineering.
• 4+ years of GMP quality assurance experience or similar role.
• 5+ years in pharmaceutical industry, preferably with starting materials and primary packaging.
• Excellent technical writing and clear communication skills.

Responsibilities

• Authoring testing strategies, specification justifications and associated specs for primary packaging materials, disposables and raw materials.
• Writing and updating SOPs within the DS and DP material area.
• Representing QC Raw Materials in tech transfer projects and customer interactions.
• Focusing on continuous improvements to processes and challenging status quo.
• Performs other duties as assigned.

Skills

Regulatory knowledge

Technical writing

Stakeholder management

Communication skills

GMP QA experience

Quality control understanding

Education

Master’s degree in Life Sciences or Engineering

Tools

Excel

LIMS

SAP

Smartsheet

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a scientist with experience in raw materials and primary packaging for drug product manufacturing. You will support the drug product area within QC Raw Materials and contribute to tech transfers for new customers and their products.

Ideal candidates have GMP QA experience, strong technical writing, and stakeholder management to align with global functions.