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Manage the CMO tech transfer and clinical/commercial manufacture: trouble shooting problems, conducting investigations, track timeline and KPIs, overseeing capacity expansion, monitoring budget, driving cost reduction and quality improvement and serve as Person in Plant.
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Is responsible for facility fit assessment, tech transfer activities, coordination of process start-up activities including Engineering Runs, GMP/clinical, PPQ and routine commercial runs, and resulting risk mitigation activities.
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Reporting to the Vice President, CMC Operations, the Head of/Senior Director CMC Operations (Drug Substance) will manage activities related to Process Development, Tech Transfer and Manufacturing of Drug substance.
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The responsibilities will be primarily to develop analytical methods and biophysical characterization assays, perform routine testing in support of formulation development and work with CRO/CMO for Drug Product analytical method tech transfer.
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Sonography Tech credentialed from the Cardiovascular Credentialing International (CCI) obtained prior to hire date or job transfer date. Cardiographic Tech credentialed from the Cardiovascular Credentialing International (CCI) obtained prior to hire date or job transfer date.
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Lead tech transfer activities as internal site transfers or transfers from client sites to BAM sites. Work closely with all departments, and other sites in developing an established checklist for proper tech transfer activities intra-site, but also inter-sites within the network.
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Experience in flow cytometry assay development, qualification, and tech transfer preferred. Provide analytical support for clinical-scale non-GMP IND-enabling manufacturing operations, including qualification of in-process and release methods and assist in tech transfer in support of GMP manufacturing and release of clinical material.
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The Senior Manager, Manufacturing Engineering will be responsible for designing for manufacturability, tech transfer, troubleshooting and manufacturing equipment of cell therapy and combination products, from clinical to early commercial manufacturing for our growing Type 1 Diabetes (T1D) program.
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Aware of what constitutes a change of condition and report to Medication Tech/Resident Care Coordinator/HSD immediately. Has knowledge of, and can demonstrate proper technique, or can learn how to assist with a gait belt, sit to stand lift, transfer board, oxygen equipment, catheter, specimen, transfer pole, trapeze, wheel chair, scale, and other equipment as directed by the Resident Care Coordinator/HSD.
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The expansion will provide additional space for the College’s programs in emergency medical services and other healthcare occupations, college transfer law enforcement, and the skilled trades. The facility will include the College’s healthcare-related programs, including nursing, surgical tech, anesthesia tech, respiratory therapy, clinical trials, and occupational therapy among others.
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Registered Sonography Tech specializing in Cardiac credentialed from the Cardiovascular Credentialing International (CCI) obtained prior to hire date or job transfer date. Registered Sonography Tech specializing in Vascular Sonography credentialed from the American Registry for Diagnostic Medical Sonography (ARDMS) obtained prior to hire date or job transfer date.
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Responsible for all aspects drug substance including conjugation process development, validation, characterization, scale-up, tech transfer, analytical method qualification, specifications, release and stability testing.
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Sonography Tech specializing in Vascular Sonography credentialed from the American Registry for Diagnostic Medical Sonography (ARDMS) and from the Cardiovascular Credentialing International (CCI) obtained within 6 Months (180 days) of hire date or job transfer date.
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The successful candidate will have deep understanding of liquid and lyophilized formulation development for biologics, protein degradation pathways, biophysical characterization studies, drug product process development, tech transfer, process characterization, risk assessment and implementation of control strategies.
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Support tech transfer of biologics drug product processes to commercial scale contract manufacturing organizations (CMOs) Demonstrated experience in tech transfer of a process from development to manufacturing or between manufacturing sites.
$156,000 - $204,750 a yearFull-timeRemoteExpandApply NowActive JobUpdated 1 month ago
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