New Product Introduction Lead

Amgen•Thousand Oaks, CA

About The Position

The Senior Associate Manufacturing role serves as the New Product Introduction (NPI) Lead for Amgen’s Thousand Oaks Drug Product facility, ATO B20. The position is responsible for introducing new products into the manufacturing plant and enabling production of programs progressing through clinical development. It owns technology transfer project planning, including NPI scope, schedule, and risk management, and acts as the interface between the Amgen network and the site’s Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering functions. The role requires substantial cross-functional collaboration and the ability to understand business and manufacturing processes, influence decisions, and drive timelines. The NPI Lead drives cross-functional projects to deliver new product introductions on time through indirect people management and effective communication. The position applies knowledge of drug product manufacturing, manufacturing operations, scientific methods, basic regulatory compliance, and quantitative and analytical troubleshooting. It also owns GMP-compliant change controls and NPI records, leads project meetings, resolves and escalates issues, and identifies process and organizational improvements. The role is part of the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20 and reports to the Manager Manufacturing Programs.

Requirements

Master’s degree in Engineering, Biology, Chemistry, or a Life Science field; or a bachelor’s degree in one of these fields and 2 years of biotechnology operations experience; or an associate degree and 4 years of biotechnology operations experience; or a high school diploma/GED and 6 years of biotechnology operations experience.
Strong organization and technical writing skills, including the ability to explain complex problems concisely to technical and management staff at varying organizational levels.
Ability to communicate through presentations and technical writing.
Ability to work independently, stay self-motivated, and multitask in a fast-paced environment.
Ability to work as a team player and demonstrate flexibility and adaptability to change.
Knowledge of drug product technical manufacturing processes, manufacturing operations, scientific methods, basic regulatory compliance expectations, and quantitative or analytical troubleshooting.

Nice To Haves

Project management experience.
Understanding of or experience in drug product formulation and vial/syringe filling operations in a GMP environment.
Direct experience in regulated environments, such as cGMP.

Responsibilities

Develop, maintain, and implement NPI project plans with support groups such as Process Development, Manufacturing, Facilities & Engineering, and Quality.
Own NPI scope, schedule, and risk management, and lead matrixed teams through influence to meet project milestones.
Resolve issues in a timely manner, drive root cause analyses, and escalate cross-functional customer concerns to management as appropriate.
Clearly communicate problem statements verbally and in writing, and provide quality-first recommendations for a path forward.
Own change controls in Trackwise, ensuring records are comprehensive and compliant with GMP procedures using a right-first-time approach.
Own NPI record documents in CDOCS (Veeva system).
Lead cross-functional team meetings and ensure NPI projects execute according to schedule.
Hold supporting functions accountable for NPI project tasks by documenting lessons learned and presenting them to management when appropriate.
Identify organizational improvement opportunities and proactively build consensus to implement them.
Conduct purposeful Gemba walks in the manufacturing plant to identify NPI-related process improvement and lifecycle management opportunities.
Report team and plant metrics to provide visibility into team operations and deliverables.