{"schemaVersion":"jobsearcher.job.v1","id":"fd87e7cfa2e119758cdad85c","url":"https://jobsearcher.com/jobs/fd87e7cfa2e119758cdad85c","canonicalUrl":"https://jobsearcher.com/jobs/fd87e7cfa2e119758cdad85c","title":"Engineer, Process Development","description":"Engineer, Process Development\nWhat you will do\nIn this role you will be a part of the Process Development Drug Substance Technology group at Amgen’s FleXBatch 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.\n\nApply a fundamental understanding of downstream bioprocessing to support biologic technology transfer, process validation, and plant startup\n\nSupport continuous process verification, monitoring, optimization, complex investigation, and product life cycle management\n\nEnsure safety and compliance of process development activities\n\nProvide process on‑floor support as required\n\nProvide support for regulatory filing, inspection, and other CMC activities\n\nResponsibilities\n\nApply fundamental scientific principles to biopharmaceutical manufacturing processes (downstream purification) in the development of process improvements, facility adaptations, and new process operations.\n\nProvide technical and on‑floor support to assist in the troubleshooting of clinical and commercial drug substance manufacturing.\n\nSupport the GMP manufacturing process evaluations and investigations.\n\nDevelop novel mammalian next‑generation technologies to increase yield, process robustness, and enable new unit operations.\n\nBasic Qualifications\n\nHigh school diploma / GED and 8 years of process science or technology transfer experience\n\nAssociate’s degree and 6 years of process science or technology transfer experience\n\nBachelor’s degree and 4 years of process science or technology transfer experience\n\nMaster’s degree\n\nPreferred Qualifications\n\n2 years of experience in a biotech/pharma process development and/or manufacturing support role for drug substance manufacturing\n\nChromatography, ultrafiltration and normal flow filtration operations experience\n\nChemical engineering principles for the scale‑up of unit operations from bench scale to commercial scale\n\nAbility to apply engineering principles and statistical analysis, including design of experiments, to solve processing issues and evaluate opportunities for process improvements\n\nExcellent written and verbal communication\n\nExperience developing and managing team training workflows and strategy\n\nDemonstrated ability to work under moderate direction\n\nAbility to analyze and interpret data\n\nSelf‑starter with the ability to take on several projects at one time\n\n#J-18808-Ljbffr","company":"Initial Therapeutics","rawCompany":"initial therapeutics","city":"Holly Springs","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-06-17T03:38:22.322Z","occupations":[{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Engineer, Process Development","description":"Engineer, Process Development\nWhat you will do\nIn this role you will be a part of the Process Development Drug Substance Technology group at Amgen’s FleXBatch 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.\n\nApply a fundamental understanding of downstream bioprocessing to support biologic technology transfer, process validation, and plant startup\n\nSupport continuous process verification, monitoring, optimization, complex investigation, and product life cycle management\n\nEnsure safety and compliance of process development activities\n\nProvide process on‑floor support as required\n\nProvide support for regulatory filing, inspection, and other CMC activities\n\nResponsibilities\n\nApply fundamental scientific principles to biopharmaceutical manufacturing processes (downstream purification) in the development of process improvements, facility adaptations, and new process operations.\n\nProvide technical and on‑floor support to assist in the troubleshooting of clinical and commercial drug substance manufacturing.\n\nSupport the GMP manufacturing process evaluations and investigations.\n\nDevelop novel mammalian next‑generation technologies to increase yield, process robustness, and enable new unit operations.\n\nBasic Qualifications\n\nHigh school diploma / GED and 8 years of process science or technology transfer experience\n\nAssociate’s degree and 6 years of process science or technology transfer experience\n\nBachelor’s degree and 4 years of process science or technology transfer experience\n\nMaster’s degree\n\nPreferred Qualifications\n\n2 years of experience in a biotech/pharma process development and/or manufacturing support role for drug substance manufacturing\n\nChromatography, ultrafiltration and normal flow filtration operations experience\n\nChemical engineering principles for the scale‑up of unit operations from bench scale to commercial scale\n\nAbility to apply engineering principles and statistical analysis, including design of experiments, to solve processing issues and evaluate opportunities for process improvements\n\nExcellent written and verbal communication\n\nExperience developing and managing team training workflows and strategy\n\nDemonstrated ability to work under moderate direction\n\nAbility to analyze and interpret data\n\nSelf‑starter with the ability to take on several projects at one time\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T03:38:22.322Z","dateModified":"2026-06-17T03:38:22.322Z","hiringOrganization":{"@type":"Organization","name":"Initial Therapeutics","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Holly Springs","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"fd87e7cfa2e119758cdad85c"},"url":"https://jobsearcher.com/jobs/fd87e7cfa2e119758cdad85c"}}