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Amgen is seeking a Principal Engineer in our Drug Substance Technology and Engineering team to be based in our Amgen Rhode Island site. The Principal Engineer will work with the Director of Process Development. This is an outstanding opportunity to take on a variety of challenges and responsibilities.
The Principal Engineer will be responsible for the technology transfer and commercial support of biologics drug substance processes at the Amgen Rhode Island Next Gen manufacturing facility. Working with a group of engineers and scientists, the Principal Engineer will lead cross functional teams at the site using engineering principles to implement manufacturing processes in a cGMP environment.
Beyond the advancement of commercial and pipeline molecules, the Principal Engineer is encouraged to drive forward functional and multi-functional initiatives employing strategic approaches.
Supervise a team of Process Development Engineers focused on upstream cell culture processes
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
Conceive plans and conduct engineering research/investigation in areas of considerable scope and complexity.
Plan, prioritize and coordinate work of a staff of engineers and/or technicians.
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.
Designs, executes, implements and directs 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.
Support extended shift as per business needs.
Doctorate degree and 2 years of Engineering and/or Operations experience
Masters degree and 6 years of Engineering and/or Operations experience
Bachelors degree and 8 years of Engineering and/or Operations experience
Associates degree and 10 years of Engineering and/or Operations experience
High school diploma / GED and 12 years of Engineering and/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 processes
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
Background working with commercial manufacture of biologics using single use technology
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 members
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
If 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.?
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