Senior Associate Manufacturing-NPI Lifecycle Management/Continuous Improvement

Career Category

Manufacturing

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

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, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• 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 discre