29 days old

Sr Associate Manufacturing

Amgen
Thousand Oaks, CA 91360
  • Job Code
    129515910
Amgen

Job ID: R-111582
Location: Thousand Oaks, CA, US

HOW MIGHT YOU DEFY IMAGINATION?

You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

SENIOR ASSOCIATE - BIOTECH/PHARMA MANUFACTURING

Live

What you will do

Let's do this. Let's change the world. In this vital role you will work with a team responsible for supporting multiple Drug Product manufacturing operations, including formulation, sterile-isolator filling, aseptic filling, and lyophilization activities. The team owns the efforts of maintaining the highest levels of safety, quality, compliance, and efficiency while balancing a dynamic production schedule. The Associate will work to support multiple internal customers and partners including Supply Chain, Quality Assurance, Process Development, and Engineering.

The Amgen, Pharma Product Manufacturing facility, in Thousand Oaks, directly supports Amgen's pipeline of clinical drug product supply to patients across the globe. The Sr. Associate Manufacturing - Drug Product role offers the opportunity to collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility!

The Senior Associate Manufacturing will be specifically responsible for:

  • Executing drug product filling and formulation activities, respectively
  • Performing initial review of manufacturing batch records
  • Maintaining a safe environment while adhering to compliance standards and by identifying additional preventative measures
  • Crafting and/or revising standard procedures
  • Leading continuous improvement initiatives, which may be multi-functional in nature
  • Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
  • Developing finite schedule for tasks including, unit operations
  • Reviewing efficiency and identifying countermeasures for issues impacting cycle time alignment
  • Elevating critical and impactful events to management
  • Utilizing appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
  • Supporting the introduction of new products and technologies into the facility
  • Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)


Win

What we expect of you

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

Preferred Qualifications:

  • At least 5 years of biopharmaceutical experience, including work within drug or pharmaceutical product manufacturing environment, which includes aseptic and sterile filling environments, as well as lyophilization
  • Bachelor's or Master's degree in Microbiology, Life Sciences, Business or a related field
  • An understanding of Lean concepts and application within a regulated manufacturing environment
  • Ability to communicate and collaborate with technical and management staff within the manufacturing, quality and process teams
  • Basic project management skills
  • Demonstrates emergent leadership traits and strong cognitive resolution abilities


Basic Qualifications:

Master's degree Or

Bachelor's degree & 2 years of operations or quality experience Or

Associate's degree & 6 years of operations or quality experience Or

High school diploma / GED & 8 years of operations or quality experience

Thrive

Some of the vast rewards of working here

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.
  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A 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-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor


Apply now

for a career that defies imagination

Objects in your future are closer than they appear. 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.



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Posted: 2021-01-30 Expires: 2021-03-02

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Sr Associate Manufacturing

Amgen
Thousand Oaks, CA 91360

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