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 Specialist Quality Control will support the HPLC/CE team by performing testing primarily supporting separation and mass spectrometric (LC/MS) testing in support of assessing the quality attributes of protein therapeutics across Amgen's development portfolio. Under minimal supervision, this position will also support HPLC/UHPLC, titer, CEX (cation exchange), Capillary Electrophoresis (CE) and HILIC (hydrophilic interaction). Staff member may also perform additional activities such as owing Change Control and Deviation records.

This role may also perform additional testing such as TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance and pH.

The environment is exciting, fast-paced and constantly evolving with varying degrees of process definition, but very rewarding for those who like hands-on science and want to make meaningful improvements in the QC space.

Key Responsibilities:

• Report, evaluate, trend and approve analytical data.

• Troubleshoot, solve problems and communicate with partners.

• Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook.

• Participate in audits, initiatives, and projects that may be departmental or organizational in scope.

• Implement protocols and perform assay transfer/validation and equipment qualification/verification.

• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

• Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports.

• Collaborate cross-functionally to drive the efficient transfer of technologies and to ensure appropriate execution of procedures and processes.

• Support introduction of new methods/techniques into the lab.

• Perform complex assay and instrument troubleshooting.

• Responsible for CEMS on call pager.

• May participate in lab investigations.

• May provide technical guidance.

• May train others.

• May represent the department/organization on various teams

• May interact with outside resources

Win

What we expect of you

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

Basic Qualifications:

Doctorate Degree

Or

Master’s degree 3 years of operations or quality experience

Or

Bachelor’s degree and 5 years of Quality and Manufacturing experience

Or

Associate’s degree and 10 years of Quality and Manufacturing experience

Or

High school diploma / GED and 12 years of Quality and Manufacturing experience

Preferred Qualifications:

• cGMP Experience

• Experience in Capillary electrophoresis

• Experience in LC/MS

• Experience using Empower CDS, LIMS and/or SmartLab

• Experience using Waters H-Class UHPLC and Agilent HPLC instrumentation

• Knowledge of analytical methods commonly used in the quality testing of Pharmaceutical Biologics

• Theoretical and practical knowledge of applying and developing separation and mass spectrometric methods for characterizing biologics

• Proven record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journal

• Experience and knowledge of Data Integrity Requirements of QC Systems

• Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)

• Excellent problem-solving capabilities and attention to detail

• Experience of collaboration within and across functional areas and outstanding customer service focus

• Excellent written and verbal communication skills

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, 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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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