Specialist Quality Control
4 weeks ago
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.
Specialist Quality Control (Chemistry)
Live
What you will do
Let's do this. Let's 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
- Associate's degree and 8 years of Quality Analytical testing experience OR
- Bachelor's degree and 4 years of Quality Analytical testing experience OR
- Master's 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.
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