Biologics NPI Lead: Upstream Readiness (Remote)

Amgen; Holly Springs (NC); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Flexible work models

Job summary

Amgen in North Carolina seeks a Specialist Manufacturing for New Product Introduction (NPI) in upstream readiness. You will interface between GMP manufacturing teams and Process Development to drive tech transfer and ensure new Drug Substance products are introduced smoothly.

Lead cross-functional meetings and improve productivity and scheduling accuracy. The role emphasizes strong project management, collaboration, and technical writing within a biologics manufacturing context, with flexible

Qualifications

• Biologics DS manufacturing experience in GMP settings.
• Strong cross-functional project management and communication skills.
• Education aligned with listed degree options.

Responsibilities

• Lead NPI coordination with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering.
• Ensure production documents are accurate and up to date.
• Support troubleshooting, RCAs and CAPA to prevent recurrence.
• Own NPI Change Controls and drive on-time completion with regulatory readiness.
• Champion Lean and Operational Excellence initiatives at the plant.

Skills

Project management

Communication

Biologics ops

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

Doctorate degree

Job description

Amgen in North Carolina seeks a Specialist Manufacturing for New Product Introduction (NPI) in upstream readiness. You will interface between GMP manufacturing teams and Process Development to drive tech transfer and ensure new Drug Substance products are introduced smoothly.

Lead cross-functional meetings and improve productivity and scheduling accuracy. The role emphasizes strong project management, collaboration, and technical writing within a biologics manufacturing context, with flexible