• Job Description

  Req#: R-183635

  Career Category

  Quality

  Job Description

  HOW MIGHT YOU DEFY IMAGINATION?

  You’ve 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 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. 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.

  Manager Quality Control Support

  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 QC Support. This group is responsible for Stability, Sample Management, Laboratory electronic systems including LIMS and Empower, Change Control, Deviations and CAPA as well as Equipment Validation and Maintenance. Responsibilities include the startup and validation of the laboratory electronic systems and equipment for the labs as well developing a complementary team of individuals. This role will support site start up and then transition to support of Amgen North Carolina commercial product release. The Manager QC Support will report directly to the Director of Quality Control and as a member of this leadership team, you will contribute to encouraging and further developing the culture of Safety, Quality, and Lean Leadership.

  Responsibilities:

  • Overall responsibility for QC support laboratories establishment and electronic systems implementation.
  • Develop the program for management of QC Change Controls, Deviations and CAPA’s
  • Oversight of the QC electronic systems including LIMS, Smartlab, Empower, CIMS and documentation system.
  • Oversight and coordination of laboratory equipment qualification across labs.
  • Experience with Maximo preferred.
  • Responsible for Stability and Sample Management programs.
  • Ensure laboratories are 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.
  • Collaborate with management on significant matters, often requiring the coordination of activity across organizational units and exercise judgment independently.
  • Translate sophisticated 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 experienced professional we seek is a dynamic team player with these qualifications.

  Basic Qualifications:

  • High school diploma / GED and 12 years of Quality Control experience OR
  • Associate’s degree and 10 years of Quality Control experience OR
  • Bachelor’s degree and 5 years of Quality Control experience OR
  • Master’s degree and 3 years of Quality Control experience OR
  • Doctorate degree

  In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

  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.
  • Able to drive process improvement within area of responsibility.
  • Able to successfully manage multiple workstreams to timelines.
  • Strong Leadership, Collaboration and Communication skills.
  • Extensive knowledge of GMP’s and regulatory guidelines.

  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

  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

  111,884.00 USD - 136,200.00 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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