New Product Introduction Lead – GMP Manufacturing

Amgen SA; Thousand Oaks (CA); In loco; USD 120.000 - 170.000; Tempo pieno

Vantaggi offerti da questo lavoro

Retirement and Savings Plan

Medical/Dental/Vision coverage

Life and Disability Insurance

Flexible Spending Accounts

Discretionary bonus program

Stock-based incentives

Descrizione del lavoro

Amgen seeks a Senior Associate Manufacturing for New Product Introduction at the Thousand Oaks DP facility (ATO B20). You will lead NPI planning, coordinate across Manufacturing, PD, QA, and Supply Chain, and drive timely NPIs from development to production.

The role requires strong project management, GMP awareness, and the ability to influence cross-functionally in a fast-paced environment. Amgen offers a comprehensive benefits package and opportunities for growth.

Competenze

• Master’s degree or equivalent in a relevant field
• Bachelor’s degree + 2 years biotech ops experience OR
• Associate’s degree + 4 years biotech ops experience OR
• High school diploma + 6 years biotech ops experience

Mansioni

• Develop, maintain, and implement the NPI project plan with PD, Manufacturing, F&E, QA
• Lead cross-functional project teams to meet NPI milestones
• Drive Root Cause Analyses and issue resolution
• Own Change Controls in Trackwise with Right-First-Time records
• Manage NPI records in CDOCS (Veeva)
• Lead cross-functional meetings to ensure timely NPI execution
• Report team and plant metrics for visibility and delivery

Conoscenze

Strong organization and technical writ

Project Management Experience

Independent, self-motivated

Team-player

Communication skills

Formazione

Master’s degree in Engineering, Biology, Chemistry or Life Science Field

Bachelor’s degree in Engineering, Biology, Chemistry or Life Science Field

Associate’s degree + 4 years biotech ops experience

High school diploma / GED + 6 years biotech ops

Strumenti

CDOCS (Veeva system)

Trackwise

Descrizione del lavoro

Amgen seeks a Senior Associate Manufacturing for New Product Introduction at the Thousand Oaks DP facility (ATO B20). You will lead NPI planning, coordinate across Manufacturing, PD, QA, and Supply Chain, and drive timely NPIs from development to production.

The role requires strong project management, GMP awareness, and the ability to influence cross-functionally in a fast-paced environment. Amgen offers a comprehensive benefits package and opportunities for growth.