New Product Introduction Lead

Amgen Australia Pty Ltd

Thousand Oaks, California, United States
Base: $86,048.05 - $116,417.95 usd; bonus/equity: ...
Master's degree in life science or engineering
Drug product formulation experience
Vial/syringe filling operations knowledge
This role serves as the New Product Introduction Lead within the Manufacturing Execution Systems team at the Thousand Oaks Drug Product facility

Job Summary

  • This role serves as the New Product Introduction Lead within the Manufacturing Execution Systems team at the Thousand Oaks Drug Product facility.
  • The incumbent will own Technology Transfer Project Planning and drive decision-making across Manufacturing, Process Development, Supply Chain, Quality, and Facilities functions.
  • Amgen offers a comprehensive benefits package including retirement plans, health coverage, stock-based incentives, and flexible work models.

Matching Summary

This role serves as the New Product Introduction Lead within the Manufacturing Execution Systems team at the Thousand Oaks Drug Product facility.

Salary

Base: $86,048.05 - $116,417.95 USD; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives; Benefits: Comprehensive health, dental, vision, retirement plan, and flexible time-off

Skills & Requirements

Must-have

  • Master's degree in Life Science or Engineering
  • Drug Product Formulation experience
  • Vial/Syringe Filling operations knowledge
  • GMP regulatory compliance understanding
  • Trackwise Change Control ownership
  • CDOCS (Veeva) record management
  • Root Cause Analysis troubleshooting

Nice-to-have

  • Strong technical writing skills
  • Project management experience
  • Self-motivated in fast-paced environment
  • Ability to manage change flexibly
  • Gemba walks for process improvement

Key Requirements

  • Master's degree in Engineering, Biology, Chemistry or Life Science
  • Bachelor's degree plus 6 months biotech operations experience
  • Direct experience with regulated cGMP environments
  • Experience owning Change Controls in Trackwise

Work Rights

Not specified

Tailored Resume

Cover Letter