Description Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility.
Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.The Engineer will apply cell culture and harvest process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology.
Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.* onsite a minimum of 3 days a week**Must have biotech background/experience, plus must have cell culture and/or purification experience Day to Day Responsibilities: Work on cell-based assay development, assay execution, and data analysis.
Maintain mammalian cell cultures.Ideally can find detail-oriented worker who can complete assigned tasks with guidanceTop 3 Must Have Skill Sets: Specifically looking for upstream experience**Strong communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.
)GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)Day to Day Responsibilities: Under guidance of senior staff, the Engineer performs the following:Transfer upstream (cell culture & harvest) drug substance processes and facilitates process improvements from the laboratory into the manufacturing facilityProvide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operationsOffer process validation support for late stage commercial processesProvide routine process monitoring and troubleshootingExecute data trending and statistical process analysisSupport technical direction for process related deviations, CAPAs and change controlsIdentify and support process related operational excellence opportunitiesRepresent process development and collaborate with other functions such as Manufacturing, Quality, Engineering and Regulatory