NPI Manufacturing Specialist — Downstream Readiness (Remote)

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

Benefits offered by this job

Medical, dental, vision

Retirement savings plan

Stock-based incentives

Annual bonuses

Flexible work arrangements

Job summary

Amgen in North Carolina seeks a Specialist Manufacturing New Product Introduction (NPI): Downstream Readiness to coordinate NPI activities for Drug Substance products and advanced tech introductions. You will drive cross‑functional meetings, ensure documentation accuracy, and lead improvement initiatives to enhance productivity and scheduling accuracy.

The role requires strong project management, GMP experience, and the ability to communicate complex technical information with diverse teams.

Qualifications

• Bachelor’s or higher degree with relevant biotech operations experience.
• Experience in GMP manufacturing operations is preferred.
• Ability to communicate complex technical information effectively.

Responsibilities

• New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities, Engineering, Quality, and other teams to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools.
• Technical expert who leads or participates in projects, ensuring that production documents are accurate and up to date.
• Support Manufacturing in troubleshooting, problem-solving and RCAs; support CAPA development to prevent error recurrence.
• Owns New Product Introduction (NPI) Change Controls and collaborates with stakeholders to drive on-time completion; responds to regulatory questions and/or audit findings.
• Champions Lean Transformation and OE initiatives, facilitates continuous improvement in the plant, and tracks progress at a plant level.

Education

High school diploma / GED & 10 years biotech ops experience

Associate’s degree & 8 years biotech ops experience

Bachelor’s degree & 4 years biotech ops experience

Master’s degree in chemistry, biology, or engineering & 2 years biotech ops experience

Doctorate degree

Job description

Amgen in North Carolina seeks a Specialist Manufacturing New Product Introduction (NPI): Downstream Readiness to coordinate NPI activities for Drug Substance products and advanced tech introductions. You will drive cross‑functional meetings, ensure documentation accuracy, and lead improvement initiatives to enhance productivity and scheduling accuracy.

The role requires strong project management, GMP experience, and the ability to communicate complex technical information with diverse teams.