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New Product Introduction Lead

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Amgen

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Location:
United States , Thousand Oaks

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Category:

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Contract Type:
Not provided

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Salary:

86048.05 - 116417.95 USD / Year

Job Description:

In this critical role for the Thousand Oaks Drug Product (DP) facility - also known as ATO B20 - you will be responsible for the introduction of new products into the manufacturing plant. ATO B20 serves as a key launch point for Amgen's new programs progressing through clinical development, and the Sr Associate Manufacturing role directly enables the production of these programs in the ATO facility. This Senior Associate Manufacturing role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20, reporting into the Manager Manufacturing Programs.

Job Responsibility:

  • Working with NPI support groups (e.g. PD, Manufacturing, F&E, QA) to develop, maintain, and implement the NPI project plan(s)
  • Resolving issues in a timely manner (i.e. drive Root Cause Analyses)
  • Owning Change Controls in Trackwise
  • Owning NPI record documents in CDOCS (Veeva system)
  • Proactively leading cross-functional team meetings
  • Holding supporting functions accountable for delivery of NPI project tasks
  • Identifying improvement opportunities within the organization
  • Performing purposeful presence Gemba walks in the manufacturing plant
  • Reporting on team and plant metrics

Requirements:

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

Nice to have:

  • Strong organization and technical writing skills
  • Project Management Experience
  • Understanding of/Experience in Drug Product Formulation and Vial/Syringe Filling operations in a GMP environment
  • Independent, self-motivated, able to multi-task in a fast-paced environment
  • Team-player
  • Demonstrated flexibility and ability to manage change
  • Direct experience with regulated environments (e.g., cGMP etc.)
What we offer:
  • Comprehensive employee benefits package including Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • Discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible

Additional Information:

Job Posted:
May 16, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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