Skip to main content

This job has expired

You will need to login before you can apply for a job.

Specialist Manufacturing - Cell Bank Manufacturing

Employer
Amgen
Location
Thousand Oaks, CA
Start date
May 24, 2022

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

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

Specialist Manufacturing- Cell Bank Manufacturing

This Specialist Manufacturing position is within Amgen Thousand Oaks Cell Bank Manufacturing organization. This role will have primary responsibility leading all aspects of the Cell Bank storage stability program with additional responsibilities supporting the cell bank manufacturing process.

Job scope and responsibilities:
  • This role will lead all aspects of the cell bank storage stability program and ensure the cell bank team is set up for success. Testing of cell banks is completed by performing cell bank vial thaw and cell expansion passages.

  • Requires strong scientific and technical understanding of mammalian cell culture processes with experience carrying out in GMP manufacturing or lab environment.

  • Ability to work cross-functionally with partner organizations such as Quality, Process Development, Supply Chain, Facilities & Engineering and Manufacturing.

  • Responsible for testing schedule and ensuring resources, equipment and raw materials have been coordinated.

  • Perform review of historical and in process data, through use of data analysis tools required to support routine testing activities and troubleshooting or investigations.

  • Own quality records such as change controls, CAPAs or deviations may be required to support the storage stability program or the broader cell bank production facility.

  • Draft documents such as SOPs, protocols, etc or own and revise procedures in support of operations.

  • Experienced with MES and drafting, revising or making routine updates to parameter lists for electronic batch records in support of operations.

  • Gain advanced user access to sample tracking and testing results software, LIMS, in support of cell bank storage stability program.

  • Champion Operational Excellence (OE) initiatives for the department and provides updates to leadership as needed.

  • Support Manufacturing in troubleshooting and investigations; conduct problem solving and RCAs; develop and own CAPAs or countermeasures to prevent recurrence.

  • Represent cell bank operations during regulatory inspections and when responding to information requests.

  • Technical authority who leads or participates in projects to introduce new products and/or technologies into the plant.

  • Experience with project management and/or developing and leading business processes.

Basic Qualifications:
  • Doctorate degree OR

  • Masters degree & 3 years of manufacturing and operations experience OR

  • Bachelors degree & 5 years of manufacturing and operations experience OR

  • Associates degree & 10 years of manufacturing and operations experience OR

  • High school diploma / GED & 12 years of manufacturing and operations experience

Preferred Qualifications:
  • Degree in Life Sciences or Engineering

  • Experience in GMP Tech Support roles, GMP operations or QC lab environment

  • Technical knowledge of mammalian cell culture processing and broad understanding of related disciplinary areas

  • Ability to coordinate, analyze, and interpret technical data through trend analysis, forecasting, modeling, etc.

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

  • Leadership experience and ability to coach, mentor and/or cross train colleagues within core technical areas

  • Background in lean manufacturing methodologies and operational excellence

Thrive

Some of the vast rewards of working here

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.

  • Full support and career-development resources to expand your skills, improve your expertise, and improve 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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
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.

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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Facebook  Social Icon - X Logo

Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert