AMGEN is looking for Process Engineers to support commercial biopharmaceutical manufacturing in Manufacturing Sciences and Technology group. Process data mining, modeling, process chemometrics, batch modeling, multivariate statistical batch SPC are among the skill set we desire to support our exciting projects on Process Analytical Technology, continuous process improvement and troubleshooting. Please find more detailed job description below. Those who are interested may contact Dr. Cenk Undey ([log in to unmask], 401-392-8245).
We are looking for an engineer/scientist to support commercial biopharmaceutical manufacturing process troubleshooting and continuous improvement efforts via advanced data mining, statistical modeling, and multivariate data analysis. This role will also include supporting Process Analytical Technologies (PAT) projects and working with analytical scientists on the application of new measurement technologies in combination with chemometrics analysis and modeling.
General responsibilities will include:
' Manufacturing support at Amgen's or contracted manufacturing sites for
' Process performance monitoring
' Development and/or use of process models (including input-output and first principles models)
' Troubleshooting of manufacturing processes, and identification of process improvement projects through advanced data analysis and statistical principles
' Provide input to corrective and preventive actions
' Support technology transfer of new processes across sites
' Support process data system improvement projects
' Perform individually or in teams; prioritize project tasks; handle multiple projects and assignments simultaneously
BS or MS degree in Biochemical, Biomedical or Chemical Engineering, or appropriate scientific field, or equivalent. At least 2 years of years experience in biopharmaceutical or pharmaceutical industry. Advanced education (e.g., Ph.D. or post-doctoral appointment) may be acceptable in lieu of industry experience. The position title may be adjusted based on the experience and expertise of the candidate.
Knowledge and skills required in one or more of the following areas:
Mammalian or bacterial cell culture, biopharmaceutical production processes including bioreactors, and/or protein purification processes and systems including chromatography, filtration and ultrafiltration
Statistical analysis (of process data for process troubleshooting, improvement and optimization studies), application of statistical principles and probability theory
' Statistical Process Control (SPC)
' Data mining (statistical, parametric and non-parametric)
' Design of Experiments (DOE) and Optimization
' Experience with statistical and data analysis/modeling software tools such as JMP, Spotfire, SIMCA and Matlab
The following skills are highly desirable:
Advanced applied statistics including multivariate analysis and chemometrics.
Process data management systems including process databases, automation systems and process data historians.
Equipment, process and software validation and change control methodology within a regulated manufacturing environment.
Experience with requirements specification development of software, equipment and processes.
Excellent written and verbal communication is essential. Strong customer orientation, collaboration and ability to lead/participate in teams are needed.
Cenk Undey, Ph.D.
Manufacturing Sciences and Technology
40 Technology Way
West Greenwich, RI 02817
Phone: 401-392-8245 Fax: 401-392-3710