Senior Associate Manufacturing-NPI Lifecycle Management/Continuous Improvement

2 months ago

Thousand Oaks, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

Lets do this Lets 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

Associates + 2 years Manufacturing and Operations work experience OR

Bachelors + 6 months Manufacturing and Operations work experience OR

Master'sPreferred 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 excellenceThrive

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 discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

Stock-based long-term incentives

Award-winning time-off plans and bi-annual company-wide shutdowns

Flexible work models, including remote work arrangements, where possibleApply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.comApplication deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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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