NPI Manufacturing Specialist: Lean Tech Transfer (Remote)

Amgen SA; Holly Springs (NC); Hybrid; USD 110,000 - 165,000; Full time

Benefits offered by this job

Comprehensive benefits package

Discretionary annual bonus

Stock-based incentives

Flexible work models including remote

Job summary

Amgen is seeking a Specialist Manufacturing for New Product Introduction (NPI) Downstream Readiness in North Carolina. You will bridge GMP manufacturing teams with Process Development to ensure successful product transfers and drive cross‑functional progress.

You will lead meetings, oversee quality and scheduling for tech transfers, and contribute to continuous improvement and operational excellence across the plant.

Qualifications

• Must have biotechnology operations experience.
• Ability to lead cross-functional projects and drive timelines.
• Strong technical knowledge of drug substance processing in bioprocessing.
• Experience with lean manufacturing methodologies and operational excellence.

Responsibilities

• Lead and coordinate New Product Introduction (NPI) projects with cross-functional teams to introduce new Drug Substance products and/or advanced technologies.
• Act as a technical expert, ensuring production documents are accurate and up-to-date.
• Support Manufacturing in troubleshooting, problem-solving, and RCAs; support CAPA development to prevent recurrence.
• Own NPI change controls and collaborate with stakeholders to drive on-time completion and respond to regulatory questions.
• Champion Lean Transformation and OE initiatives, tracking plant-wide progress.

Skills

Project management

Cross-functional collaboration

Technical writing

Process development

Education

High school diploma or GED

Associate’s degree

Bachelor’s degree

Master’s degree

Doctorate degree

Job description

Amgen is seeking a Specialist Manufacturing for New Product Introduction (NPI) Downstream Readiness in North Carolina. You will bridge GMP manufacturing teams with Process Development to ensure successful product transfers and drive cross‑functional progress.

You will lead meetings, oversee quality and scheduling for tech transfers, and contribute to continuous improvement and operational excellence across the plant.