New Product Introduction Lead

About the Position

New Product Introduction Lead

Location: Thousand Oaks, California, United States

Work Location Type: On Site

Job ID: R-257966

Date Posted: Oct. 13, 2026

Category: Manufacturing

Salary Range: 86,048.05 USD - 116,417.95 USD

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Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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Responsibilities

As a Senior Associate Manufacturing - Building 20 Drug Product Manufacturing New Product Introduction (NPI), you will be responsible for:

• Maintain an organized way of working with NPI support groups (e.g., PD, Manufacturing, F&E, QA) to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
• Resolve issues in a timely manner (i.e., drive Root Cause Analyses) and elevating cross-functional customer concerns to various levels of management as appropriate.
• Articulate problem statements verbally and in writing to management, with a quality-first mindset for recommendations for path forward.
• Own Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
• Own NPI record documents in CDOCS (Veeva system).
• Lead cross-functional team meetings to ensure NPI project(s) execute per schedule.

Additional Responsibilities include:

• Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
• Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
• Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
• Reporting on team and plant metrics to ensure visibility to team operations and deliverables.

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Requirements

Basic 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 of 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

Preferred Qualifications:

• Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff of varying organizational levels in both presentation and technical writing forms.
• 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.).

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We Offer

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

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About the Company

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Apply now and make a lasting impact with the Amgen team.

careers.amgen.com