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.
What you will do
Lets do this. Lets change the world. In this vital role you will be the technical-lead and people-manager for our Upstream Process Engineering team at our multiproduct facility at the Rhode Island Site. This facility manufactures a range of innovative biologic and biosimilar medicines. The Principal Engineer will lead a team focused on bioprocess cell culture process optimization, drug substance manufacturing support and new product introductions. 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.
- Supervise a team of Process Development Engineers focused on upstream cell culture processes
- Plan, prioritize and coordinate work of a staff of engineers and/or technicians
- Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity
- Collaborate with Plant Managers, i.e., Production Managers and Senior Process Development staff to assess needs and update progress
- Perform work that involves in-depth investigation of subject area
- Lead efforts with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing recommendations for large and/or highly complex system/facility or process modifications
- Design, execute, implement, and direct engineering or process projects which significantly contribute to attaining high priority goals
- Interpretation of Processes Characterization
- Establish Testing Strategies
- Design / Development of Characterization Protocols
- Technical Reports Development
- Validations, and technical reports- support SATs executions, document generation and challenge validations strategies
- Risk assessments and QRAES knowledge, to support risk assessments activities
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 strong communicator with these qualifications.Basic Qualifications
- Doctorate degree and 2 years of Engineering or Operations experience OR
- Masters degree and 6 years of Engineering or Operations experience OR
- Bachelors degree and 8 years of Engineering or Operations experience OR
- Associates degree and 10 years of Engineering or Operations experience OR
- High school diploma / GED and 12 years of Engineering or Operations experience
- 8+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing
- Proven ability to lead and deliver results in a highly fluid, interactive matrixed environment
- Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
- Strong understanding cGMP requirements
- Knowledge of regulatory filings and inspections
- Upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP) including technical support for nonconformance investigations and other commercial support activities
- Experience working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for biological molecules
- Deep understanding of operational aspects of biopharma and/or engineering industries
- Ability to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
- Skills in analysis of data generated using different analytical techniques
- Strong oral and verbal communication and presentation skills enabling strong relationships with internal and external partners
- Ability to derive insightful strategies to improve business processes
- Experience in supervision of direct reports and mentoring of matrix-team member
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.