29 days old

Manufacturing Specialist - MES Lead

Amgen
Thousand Oaks, CA 91360
  • Job Code
    134029424
Amgen

Job ID: R-115887
Location: Thousand Oaks, CA, US

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. 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. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

MANUFACTURING SPECIALIST - MES LEAD

Live

What you will do

Let's do this. Let's change the world. In this vital role you will act as the Manufacturing Execution Systems (MES) Lead for GMP Drug Substance Supply (DSS). This position is within Amgen Thousand Oaks (ATO) Manufacturing and Clinical Supply - Manufacturing Systems organization.

ATO DSS is a dynamic environment and an important launch point for Amgen's pipeline products. The GMP DSS plants manufacture drug substance for clinical trials through commercial production using both stainless steel and single-use equipment platforms. This role is a key communication and technical interface function and the Specialist Manufacturing - MES Lead will act as a liaison between the GMP manufacturing operations teams and NPI, Supply Chain, Facilities & Engineering, and Process Development.

Job scope and responsibilities:

  • Manufacturing Execution Systems (MES) Lead will be responsible for the design, authoring, implementation and validation of the Electronic Batch Records used in the plants.
  • Directly manage a small team of MES editors.
  • Lead the troubleshooting, problem solving and RCAs associated with MES. Develop and own countermeasures to prevent error recurrence.
  • Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement and data digitization in the plant. Leads integration with data management tools.
  • Collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings associated with MES in the plant.
  • Technical expert who leads or participates in projects to introduce new digital technologies into the plant.
  • Represents the plant on global MES network and initiatives.


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The biotech/pharma professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications:

Doctorate degree OR

Master's degree in chemistry, biology, computer science or engineering and 3 years of MES biotechnology operations experience OR

Bachelor's degree and 5 years of MES biotechnology operations experience OR

Associate's degree and 10 years of MES biotechnology operations experience OR

High school diploma / GED and 12 years of MES biotechnology operations experience

Preferred Qualifications:

  • Extensive experience with electronic documentation systems in a regulated environment
  • Experience with PAS X, Werum software with capability to create and edit in EBR
  • Experience in GMP operations
  • Technical knowledge of biotechnology cell culture and drug substance purification operations
  • Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
  • Ability to coach, mentor and/or cross train colleagues within core technical areas
  • Background in lean manufacturing methodologies and operational excellence
  • Experience in cross functional Project Management
  • Experience validating computer based systems


Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits


Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

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 a 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 an accommodation.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.





PI134029424

Categories

Posted: 2021-04-14 Expires: 2021-05-15

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Manufacturing Specialist - MES Lead

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast