New Product Introduction Lead – Drive Biotech Launches

Amgen; California; On-site; USD 86,000 - 116,000; Full time

Benefits offered by this job

Retirement plan

Medical and dental insurance

Stock-based incentives

Flexible work model

Job summary

Amgen in Thousand Oaks, CA is seeking a Senior Associate Manufacturing for Building 20 DP New Product Introduction. You will lead NPIs, coordinate with PD, Manufacturing, QA, and Facilities to ensure on-time transfer and startup of new products.

The role emphasizes Change Controls in TrackWise, CDOCS, and cross-functional collaboration, with a focus on quality, regulatory compliance, and meeting aggressive project milestones.

Qualifications

• Master’s degree in Engineering, Biology, Chemistry or Life Science Field OR
• Bachelor’s degree in Engineering, Biology, Chemistry or Life Science Field and 2 years biotechnology operations experience OR
• Associate’s degree and 4 years of biotechnology operations experience OR
• High school diploma / GED and 6 years of biotechnology operations experience

Responsibilities

• Maintain an organized way of working with NPI support groups to develop, maintain, and implement the NPI project plan(s) and meet milestones
• Resolve issues in a timely manner and drive Root Cause Analyses
• Clearly articulate problem statements verbally and in writing to management with a quality-first mindset
• Own Change Controls in Trackwise and CDOCS to ensure records are compliant per GMP
• Proactively lead cross-functional team meetings to execute NPIs on schedule

Job description

Amgen in Thousand Oaks, CA is seeking a Senior Associate Manufacturing for Building 20 DP New Product Introduction. You will lead NPIs, coordinate with PD, Manufacturing, QA, and Facilities to ensure on-time transfer and startup of new products.

The role emphasizes Change Controls in TrackWise, CDOCS, and cross-functional collaboration, with a focus on quality, regulatory compliance, and meeting aggressive project milestones.