Senior Associate Manufacturing-NPI Lifecycle Management/Continuous Improvement

Career Category

Manufacturing

Job Description

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. 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.

Senior Associate Manufacturing-NPI Lifecycle Management/Continuous Improvement

Live

What you will do

Let’s do this! Let’s change the world! In this vital role you will communicate and work with the New Product Introduction Leads and the GMP Manufacturing teams in the plant.

This Senior Associate Manufacturing position is within Amgen Thousand Oaks Drug Substance Supply (Manufacturing) organization and will be focused on lifecycle management of existing products and NPI continuous improvement initiatives for cell culture, harvest, and purification operations.

Job scope and responsibilities:

• Lead the development and implementation of improvement strategies to enhance the NPI process, focusing on efficiency, quality, and safety.

• Collaborate and communicate with Manufacturing, Quality Assurance, and other departments to ensure seamless integration of advancement initiatives.

• Lead root cause analysis for issues arising during the NPI process, driving corrective and preventive actions to mitigate risks through long-term solutions.

• Manage multiple continuous improvement projects simultaneously, ensuring they are completed on time and within scope.

• Ensure all process improvements are documented and align with industry regulations and company policies.

• Own and manage change controls records.

• Support NPI Lead and participate in various aspects of clinical or commercial NPI projects.

• Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence.

• Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant and track progress on a plant level.

• Generate and/or revise electronic and paper process documents to ensure plant success.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The knowledgeable professional we seek is a strong leader with the following qualifications:

Basic Qualifications:

• High school/GED + 4 years Manufacturing and Operations work experience OR

• Associate’s + 2 years Manufacturing and Operations work experience OR

• Bachelor’s + 6 months Manufacturing and Operations work experience OR

• Master's

Preferred Qualifications:

• Degree in Chemical Engineering, Industrial Engineering, Biology or Biochemistry

• Excellent technical writing skills and experience with electronic documentation systems

• Experience with PAS X, Werum software with capability to edit EBRs

• Experience in GMP operations

• Knowledge of drug substance cell culture/harvest bioprocessing and/or knowledge of downstream bioprocessing (chromatography, filtration, buffer compounding)

• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms

• Background in LEAN manufacturing methodologies and operational excellence

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents,