Remote NPI Lead, Downstream Readiness and Process Transfer

BioSpace; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits

Discretionary bonus

Remote work options

Job summary

Amgen in North Carolina is seeking a Specialist Manufacturing for New Product Introduction (NPI) - Downstream Readiness. The role interfaces between GMP manufacturing teams and Process Development to ensure successful tech transfer of new Drug Substance products into the plant.

You will lead cross-functional meetings, coordinate with multiple teams, and drive timelines to support product introductions, while proposing enhancements to improve productivity and scheduling accuracy.

Qualifications

• High school diploma or equivalent with biotechnology operations experience.
• Associates degree with biotechnology operations experience.
• Bachelor’s degree with biotechnology operations experience.
• Master’s degree in chemistry, biology, or engineering with 2+ years of biotech ops experience.
• Doctorate degree in a relevant field.

Responsibilities

• Lead cross-functional NPI activities to transfer new Drug Substance products into the NC biologics facility.
• Coordinate with Manufacturing, Process Development, Supply Chain, Planning, Facilities, Engineering, Quality and others to drive on-time tech transfer.
• Support troubleshooting, problem-solving, and RCAs; contribute to CAPA development.
• Own NPI change controls and respond to regulatory questions/audits.
• Champion Lean and OE initiatives to improve productivity and scheduling.

Skills

Biotech operations

Cross-functional PM

Technical writing

GMP manufacturing

Problem solving

Education

High school diploma

Associates degree

Bachelors degree

Masters degree

Doctorate degree

Tools

Process development

Job description

Amgen in North Carolina is seeking a Specialist Manufacturing for New Product Introduction (NPI) - Downstream Readiness. The role interfaces between GMP manufacturing teams and Process Development to ensure successful tech transfer of new Drug Substance products into the plant.

You will lead cross-functional meetings, coordinate with multiple teams, and drive timelines to support product introductions, while proposing enhancements to improve productivity and scheduling accuracy.