• Job Description

  Req#: R-177910

  Career Category

  Operations

  Job Description

  HOW MIGHT YOU DEFY IMAGINATION?

  If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

  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.

  Senior Manager Quality Control Bioassay

  Live

  What you will do

  Let’s do this. Let’s change the world. In this vital role, you will lead a team responsible for the QC Bioassay 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 Bioassay will report directly to the Director of Quality Control and as a member of this leadership team will contribute to fostering and further developing the culture of Safety, Quality, and Lean Leadership.

  Responsibilities:

  • Overall responsibility for startup and day to day function of the QC Bioassay Laboratory. This includes ELISA and cell-based methods.
  • Ensure the laboratory is operated in compliance with safety guidelines, cGLPs, cGMPs and other applicable regulatory requirements.
  • Creation and approval of SOP’s, trend data, investigations, deviations, validation protocols, reports, method validation/verifications and equipment qualifications.
  • Participate in regulatory agency inspections and support site licensure.
  • Establish and enable LEAN principles across all areas of responsibility.
  • Establish and enable department goals, strategies and KPIs.
  • Interface with management on significant matters, often requiring the coordination of activity across organizational units and exercise judgment independently.
  • Translate complex data into actionable information and apply strong technical knowledge to meet business objectives.
  • Identify process gaps, introduce innovative solutions, and lead operational excellence projects within the Amgen global QC network to improve efficiency and productivity, while decreasing expense/operating costs

  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:

  Doctorate degree and 2 years of Quality Analytical testing experience

  Or

  Master’s degree and 6 years of Quality Analytical testing experience

  Or

  Bachelor’s degree and 8 years of Quality Analytical testing experience

  Or

  Associate’s degree and 10 years of Quality Analytical testing experience

  Or

  High school diploma / GED and 12 years of Quality Analytical testing experience

  And

  2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

  Preferred Qualifications:

  • Degree in Scientific Field such as Molecular Biology, Biochemistry or Pharmaceutical Sciences
  • Previous experience in Qualification and Validation of Equipment and test methods
  • Strong knowledge of aseptic techniques
  • Strong knowledge of cGMPs and experience interacting with Regulators
  • Able to drive process improvement within area of responsibility
  • Able to successfully manage multiple workstreams to timelines
  • 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.

  Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

  Apply now

  for a career that defies imagination

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

  careers.amgen.com

  #AmgenNorthCarolina

  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 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.

  .

  Salary Range

  126,081.00 USD - 155,021.00 USD

• About the company

  Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

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