- Repligen (Waltham, MA)
- … systems , and process analytical technologies. Experience with mammalian cell culture, particularly Chinese Hamster Ovary (CHO) cells for monoclonal antibody ... OverviewWe are seeking a highly skilled and motivated Senior Cell Culture Scientist to join our Advanced Bioprocess Applications...cell culture processes, particularly ATF and TFF perfusion systems , at PD scale (ie 0.5 to 20L).Strong background… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …role is an exempt level position with responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support both ... preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.GxP Quality System knowledge, including relevant regulations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy manufacturing plant to support ... protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy ... diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …relevant experience is required. Demonstrated experience translating business needs to system requirements. Cell /Gene Therapy cGMP manufacturing and project ... of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development...IT to drive the design and implementation of new system updates for cell therapy development and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous ... and allogenic chimeric antigen receptor T- cell , T- cell receptor (TCR-T), and natural killer...identify root cause and appropriate corrective actions for equipment system problemsHelps support the optimization of calibration frequencies through… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous ... and allogenic chimeric antigen receptor T- cell , T- cell receptor (TCR-T), and natural killer (NK) cell -based immunotherapy. From our three R&D sites around… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous ... and allogenic chimeric antigen receptor T- cell , T- cell receptor (TCR-T), and natural killer...time in a manner consistent with safety policies, quality systems , and cGMP requirements.Build strong partnerships with Manufacturing, Warehouse,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous ... and allogenic chimeric antigen receptor T- cell , T- cell receptor (TCR-T), and natural killer...process and developing mitigation plans.Proficient in working with ERP Systems (S/4 HANA preferred).Knowledge of sourcing process and demonstrated… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …qualification of facility and equipment for new projects and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification ... diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous… more
- Merck & Co. (San Diego, CA)
- …data to advance our company's Immunology portfolio (eg, bulk RNAseq, single cell RNAseq, spatial Tx, imaging and HT proteomics).Apply advanced statistical inference ... biology and data science approaches to integrate muti-resolution (bulk, single cell , spatial) transcriptomic and epigenomic profiling data derived from patient… more
- Twist BioScience (South San Francisco, CA)
- …system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS, QMS) using ... Sr. Director, Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe...define MES requirements, design seamless integrations with other enterprise systems (eg, ERP, LIMS, QMS), and ensure compliant data… more
- Aequor (Waltham, MA)
- …Perform QA/client review for internal and/or CMO Quality System records, manufacturing documents, analytical methods, and qualification/validation documentation. ... Ensure all necessary documents/forms/records are authorized to facilitate movement of cell product to clinical sites Support Manufacturing to collect and monitor… more
- Merck & Co. (North Wales, PA)
- …and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Director, Quantitative Systems Pharmacology (QSP) . QP2-IO team is part of the Global Clinical ... small molecules and biologics (monoclonal antibodies, antibody drug conjugates, T- cell engagers, bispecifics) in Oncology, authoring regulatory documents (investigational… more
- Eisai, Inc (Exton, PA)
- …the individual will be responsible to maintain and/or enhance the production area systems and technology to remain compliant with regulations and to ensure the ... commissioning and managing biologics production areas. Knowledgeable in mammalian cell culture, microbial fermentation, purification, biologics equipment operation, and… more
- Merck & Co. (Rahway, NJ)
- …multiple strategies to create genetic diversity, multiple host organisms and/or cell free expression systems , and/or multiple high-throughput screening/selection ... Data-Driven Decision Making, Flow Cytometry, High Throughput Screening HTS Systems , Immunochemistry, Mass Spectrometry Based Proteomics, Microbiology, Microfluidics, Molecular… more
- Genmab (NJ)
- …readiness, and regulatory compliance.Act as a Data Standards or Clinical Systems Lead as needed.Regulatory and Submission SupportContribute to submission readiness ... quality management, and protocol deviation oversight.Strong knowledge of EDC systems , data reconciliation practices, and industry data standards (eg,… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …areas. The Research Associate will be responsible for maintenance of continuous cell cultures, accurate and complete study records, supply inventory, and laboratory ... of Microsoft Office, as well as the ability to learn department-specific computer systems as needed. This position may involve work inside the ABSL3 facility which… more
- Genmab (NJ)
- …labeling documents; Maintain and track labeling documents in the electronic system as appropriate.Participate in the development and maintenance of SOPs, work ... data sciences, resulting in a proprietary pipeline including bispecific T- cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and… more
- Genmab (NJ)
- …randomization and stratification plans Perform UAT of Randomization part of the IRT system as applicable Ensure procedures for blinding are in place as applicable ... data sciences, resulting in a proprietary pipeline including bispecific T- cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and… more
