NPI Manufacturing Specialist — Remote-Ready & Impactful

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision

Life and disability insurance

Stock-based incentives

Flexible time off

Remote work options

Job summary

Amgen North Carolina Biologics Drug Substance Manufacturing plant seeks an experienced Senior Associate Manufacturing for New Product Introduction systems. You will coordinate cross-functional activities to enable compliant and timely implementation, focusing on QRAs, FMEAs, and change controls.

This role requires strong documentation, quality-system skills, and the ability to navigate ambiguity while building relationships across Manufacturing, Quality, Process Development, and Supply Chain.

Qualifications

• Experience in GMP manufacturing or manufacturing support.
• Strong cross-functional coordination and meeting facilitation.
• Technical writing and thorough documentation skills.
• Familiarity with Quality Management Systems and change controls.
• Ability to manage multiple priorities and strict timelines.
• Experience with QRAs and FMEAs is a plus.

Responsibilities

• Coordinate New Product Introduction (NPI) programs with cross-functional teams.
• Lead QRAs, FMEAs, risk action logs, and associated records.
• Create and maintain process Bills of Materials (BOMs).
• Coordinate BOM inputs across Supply Chain, MES, SUS, Manufacturing.
• Own NPI Change Control records and planning.
• Track pre-/during-/post-implementation tasks and deliverables.
• Maintain trackers and provide status updates to NPI management.
• Build cross-functional relationships and solve problems to enable timely execution.

Skills

GMP manufacturing

Cross-functional coordination

Meeting facilitation

Technical writing

Quality-system knowledge

Effective communication

Education

Master's degree

Bachelor's degree in Manufacturing or related field

Associates degree in a related field

High school diploma or GED

Tools

Veeva QMS

TrackWise

Job description

Amgen North Carolina Biologics Drug Substance Manufacturing plant seeks an experienced Senior Associate Manufacturing for New Product Introduction systems. You will coordinate cross-functional activities to enable compliant and timely implementation, focusing on QRAs, FMEAs, and change controls.

This role requires strong documentation, quality-system skills, and the ability to navigate ambiguity while building relationships across Manufacturing, Quality, Process Development, and Supply Chain.