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Specialist Quality Control (Chemistry)

Employer
Amgen
Location
Holly Springs, North Carolina
Start date
Sep 27, 2024
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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Specialist Quality Control (Chemistry)

Live

What you will do

Lets do this. Lets change the world. In this vital role you will direct a team responsible for the QC Chemistry laboratory. Responsibilities include the startup and validation of the laboratory equipment and transfer of analytical methods as well developing a diverse team of individuals to deliver site start up and then transition to support of Amgen North Carolina commercial product release. Scope includes in-process, release, stability, and characterization testing. The Senior Manager QC Chemistry will report directly to the Director of Quality Control and as a member of this leadership team will contribute to encouraging and further developing the culture of Safety, Quality, and Lean Leadership.

  • Assist with planning and execution of equipment installation and qualification within the QC Chemistry lab to support startup and day-to-day functions.
  • Responsible for operating robust analytical testing for biologic products under cGMP criteria.
  • Leading transfer, qualification, and/or validation for the sophisticated chemical procedures.
  • Author, revise, and review documents and reports including SOPs, safety assessments, methods, trend reports, qualification/validation summary reports, technical reports, and method assessments.
  • Assist with planning, scheduling, and execution of daily activities.
  • Participate in Laboratory administration, including Out-of-specification and non-conformance arising
  • Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
  • Own, lead, and participate in deviations, CAPAs, and cross functional investigations.
  • Training of junior staff in chemistry techniques and assays.
  • Ensure the laboratory is operated in compliance with safety guidelines, cGLPs, cGMPs and other applicable regulatory requirements.
  • Work with management on important matters, often requiring the coordination of activity across organizational units and exercise judgment independently.

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 a dynamic, flexible, and driven leader with these qualifications.

Basic Qualifications:

  • High school diploma / GED and 10 years of Quality Analytical testing experience OR
  • Associates degree and 8 years of Quality Analytical testing experience OR
  • Bachelors degree and 4 years of Quality Analytical testing experience OR
  • Masters degree and 2 years of Quality Analytical testing experience OR
  • Doctorate degree

Preferred Qualifications:

  • Experience working in a GMP Quality Control Chemistry Laboratory.
  • Degree in Scientific Field such as Chemistry or Pharmaceutical Sciences or related scientific field.
  • Previous experience in Qualification and Validation of Equipment and test methods
  • Experience with Chemistry Quality Control testing, including but not limited to: HPLC, UPLC, Concentration and USP-NF methods.
  • Strong written and verbal communication skills, including technical writing and technical presentations.
  • Strong Leadership, Collaboration and Communication skills.

Thrive

What you can expect of us

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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

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

careers.amgen.com

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.

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

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