Career Category

Job Description

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.

Live

What you will do

Let’s do this. Let’s change the world.

The Senior Associate in the Bioassay group within Amgen’s Quality Control organization will work in a dynamic team environment to support testing, and projects within the group. The position will perform data analysis using R-based Bioassay Data Analysis (RBDA) while documenting results in an electronic lab notebook (ELN) or on paper forms, as well as, in a laboratory information management system (LIMS), and will be responsible for lab activities including analytical testing and approving, equipment maintenance, method validation, qualification and transfer, interacting with and/or presenting to internal and external inspectors all while providing technical expertise. The Senior Associate may also be responsible for ownership activities including Standard Operating Procedures (SOPs), deviations, out of specification (OOS) and unexpected results (UR) investigations. They will work in a team environment, collaborating with various colleagues in Amgen while providing mentorship and acting as a training resource.

Responsibilities:

Testing

• Align with safety guidelines

• Follow Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMPs), which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory log books

• Complete routine and non-routine testing procedures and assays

• Create and review methods and procedures for completeness and accuracy

• Maintain testing equipment at a high level to quality to ensure accuracy and consistency of test results

• Perform data analysis of testing results and communicate results to appropriate sources

Material/Data Management

• Responsible for documenting, computing, compiling, interpreting, reviewing, and entering data

• Responsible for the inventory management of all media and reagents

• Partner with subject-matter-experts and/or responsible for the execution of special project studies

• Ensure the timely disposal of tested samples

Qualification/Validation

• Responsible for managing and performing and/or supporting method qualifications and validations

Non Conformance

• Support non conformances and investigations as a subject matter expert

• Own and manage QC related non conformances

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality Control professional we seek is an employee with these qualifications.

Basic Qualifications

Master’s degree

Or

Bachelor’s degree and 2 years of Quality or Operations experience

Or

Associate’s degree and 6 years of Quality or Operations experience

Or

High school diploma / GED and 8 years of Quality or Operations experience

Preferred Qualifications

• Bachelor's degree in Biological Sciences

• 5+ years’ experience with mammalian cell culture and bioassay analytical methods

• 5+ years of biopharmaceutical experience with increasing responsibility in the organization

• Experience in biotechnology with cGMP regulations, practices and requirements pertaining to the manufacturing and testing of biopharmaceuticals with a track record of strong scientific contributions and project leadership

• Demonstrated ability to independently identify, develop and implement scientific solutions to practical problems; ability to apply established platform approaches and use solid problem-solving skills as well as out-of-the-box thinking to contribute to technology improvements

• Knowledge and experience with data trending, metrics generation, authoring protocols/reports, and authoring SOPs and using Safety Data Sheets (SDS)

• Experience working with internal and external inspectors

• Demonstrated in-depth knowledge of laboratory equipment and operations, including working with hazardous compounds and chemicals

• Demonstrated communication (written and verbal) and scientific writing skills

• Ability to complete projects as part of a team or independently

• Knowledge in continuous improvement tools and methodologies, familiarity with Lean Transformation process and associated Operational Excellence tools

• Ability to make decisions in a timely and thoughtful manner, taking in consideration available information

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 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 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.

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