HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Senior Manager Quality Control Microbiology
What you will do
Does the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and high performing teams? If you have a passion for talent development and want to be a part of Amgens mission to serve patients every patient every time then check out this exciting new opportunity.
Amgen, one of the worlds leading biotechnology companies, is investing $550 million to build a new multi-product drug substance biomanufacturing facility in Holly Springs, North Carolina, a biomanufacturing hub known for their life sciences industry. The new plant will combine two production formats, traditional stainless-steel fed-batch and single-use technology. This combination of capabilities is an approach that Amgen calls FleX Batch manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability, aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgens plan to be carbon neutral by 2027.
The investment will bring approximately 355 jobs comprised of highly skilled workers that will be built on a foundation that promotes diversity, inclusion and belonging. The site will include the manufacturing plant, warehouse, central utilities and office space. Amgen is targeting 2024 for site completion.Live
What you will do
Lets do this. Lets change the world! In this vital role you will lead a team responsible for the QC Microbiology and PCR laboratories. Responsibilities include clean utilities qualification, establishment of the environmental monitoring program 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 routine monitoring testing. The Senior Manager QC Microbiology 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 Microbiology and PCR Laboratories. This includes Identification testing and Clean Utility Monitoring processes ownership, Environmental Monitoring and Product Testing program as well as PCR testing
- Ensure the laboratory is operated in compliance with safety guidelines, cGLPs, cGMPs and other applicable regulatory requirements
- 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 dynamic professional we seek is a flexible and driven individual with these qualifications.
- Doctorate degree and 2 years of Quality or Aseptic Manufacturing experience Or
- Masters degree and 6 years of Quality or Aseptic Manufacturing experience Or
- Bachelors degree and 8 years of Quality or Aseptic Manufacturing experience Or
- Associates degree and 10 years of Quality or Aseptic Manufacturing experience Or
- High school diploma / GED and 12 years of Quality or Aseptic Manufacturing experience And 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
- Degree in Microbiology, Molecular Biology, or Pharmaceutical Sciences
- 2+ years of management experience at a senior level
- Previous experience in Quality Implementation of Environmental and Utilities Monitoring processes
- Strong knowledge of aseptic technique
- 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 our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.com
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, 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.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.