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.
Principal Engineer/Senior Manager, Process Development
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 bio-manufacturing facility in Holly Springs, North Carolina, a bio-manufacturing 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.
Lets do this. Lets change the world! In this vital role you will provide scientific and technical leadership within the Process Development Drug Substance Technology group at Amgens FleX Batch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.
- Lead a technical team focused on biologics technology transfer, process validation, and plant start-up support
- Lead site activities for continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management
- Ensure safety and compliance of process development activities
- Collaborate with other site-functions and network drug substance teams in delivering plant goals
- Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
- Assure manufacturing operations are aligned with the registered process
- Provide support for regulatory filing, inspection, and other CMC activities
- Serve as member of the Drug Substance Technology (DST) extended leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities
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 collaborative partner with these qualifications.
- Doctorate Degree and 2 years of biologics process development or commercial-scale technical support experience Or
- Masters Degree and 6 years of biologics process development or commercial-scale technical support experience Or
- Bachelors Degree and 8 years of biologics process development or commercial-scale technical support experience Or
- Associates degree and 10 years of biologics process development or commercial-scale technical support experience Or
- High school diploma / GED and 12 years of biologics process development or commercial-scale technical support experience
- 8+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
- 5+ years of management experience
- Strong and in-depth expertise in process cell culture and/or purification processes
- Experience in process scale-up, technology transfer, process validation, troubleshooting, and complex investigation
- Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
- Experience developing staff to reach their full potential
- Knowledgeable in regulatory filings and inspections
- Familiarity in operational aspects of commercial biopharma manufacturing
- Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing
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.