Senior Manager Quality Control Bioassay

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Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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

What you will do

Lets do this. Lets 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.

• 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 SOPs, 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

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 12 years of Analytical testing experience OR
• Associates degree and 10 years of Analytical testing experience OR
• Bachelors degree and 8 years of Analytical testing experience OR
• Masters degree and 6 years of Analytical testing experience OR
• Doctorate degree and 2 years of Analytical testing experience

And

• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years 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
• 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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.

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