- Eisai, Inc (Chicago, IL)
- …of contact between Eisai and formulary decision-makers within identified Health Systems representing Eisai's product portfolio.The Health System Account ... for creating access to Eisai's product portfolio in identified Health Systems while building a strong corporate presence with formulary decision-makers and… more
- BioAgilytix (San Diego, CA)
- … Systems Analyst is responsible for providing support to projects related to validated computerized systems and the overall corporate infrastructure.Essential ... less than three (3) years' direct hands-on experience with computer systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level position with...assurance, manufacturing compliance, clinical quality, or cell therapy.GxP Quality System knowledge, including relevant regulations and guidances (eg 21… more
- Merck & Co. (Rahway, NJ)
- …BS/BA or an equivalent certification/experience in science, engineering, IT or related discipline with functional working experience in System ... will include:Project support for System Development, Maintenance, Enhancement and System Monitoring related initiatives.Serve as a liaison between the Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …API requirements (no development experience required) in and out of Veeva CRM system .- Documentation: Document various system related documentations such as ... Qualifications (from an accredited college or university)Bachelor's Degree in Information Systems , Computer Science or business related discipline required… 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 are seeking an experienced and highly motivated Manufacturing… more
- Merck & Co. (Durham, NC)
- …Skills:Building Automation Systems , Computerized Maintenance Management Systems (CMMS), Electrical System Troubleshooting, Equipment Maintenance, ... holidays.Key Responsibilities:Must have knowledge installing, repairing, and maintaining mechanical related equipment throughout a Manufacturing environment to include:Utility equipment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide ... systems .Assist in the development of validation and qualification related policies, procedures, templates, formsProvides quality oversight on data integrity of… more
- Merck & Co. (Rahway, NJ)
- …participate in Quality Notification (QN) reporting, investigations, and any related corrective action/preventive action (CAPA).- Facilitate equipment/ system ... and developmental supplies for sterile products, including critical program needs related to new products undergoing process development, new products undergoing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …room HVAC, refrigeration, pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor ... OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... overtime, as needed.Preferred Experience and Skills:Associate Degree in Industrial Systems , Mechanical, Electronics, Electrical or InstrumentationSAP experience related… more
- Aequor (Athens, GA)
- …P&ID's. Assists the team with maintaining an up-to-date working spare parts inventory system for equipment/ systems . Completes all work in accordance with CFRs, ... and Clean Utilities including: plumbing, mechanical, electrical, HVAC, high purity water systems , clean steam, cold storage, fire systems and compressed air.… more
- Aequor (Vacaville, CA)
- …of bio-tech related analytical methods and practices Experience with analytical systems , data analysis, and troubleshooting Knowledge of SAP system is a ... be primarily accountable for ensuring your assigned Process Analytical Technology (PAT) Systems deployed on the manufacturing floor are fit for purpose and ready… more
- Merck & Co. (Rahway, NJ)
- …and external to GCS and serve s as the GCS spokesperson at clinical development related meetings (i .e., Clinical Trial Team s ) and product development related ... and other supply chain areas to address clinical supply related topics . - Responsible and accountable for establishing...and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for… more
- Repligen (San Diego, CA)
- …technical assistance and expertise to the CTI/Repligen sales force and customers related to the laboratory instrumentation its sells and supports. The laboratory ... by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and… more
- Merck & Co. (Durham, NC)
- …Must have knowledge installing, repairing, and maintaining mechanical related equipment throughout a Manufacturing environment to include:Utility equipment ... osmosis skids, vapor compression stills, compressed gas systemsGMP production related equipment (eg Autoclaves, Fillers, Lyophilizers, Cappers and Automated… more
- Merck & Co. (Rahway, NJ)
- …and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the Program CSPM designs strategic and operational ... chain areas to negotiate timelines ,- strategies and other related topics for all clinical supplies across all assigned...assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for… more
- Novo Nordisk Inc. (Boston, MA)
- …player in defeating other serious chronic conditions such as obesity, growth hormone- related disorders and rare bleeding disorders. We use our skills, dedication and ... Nordisk within a specified geographic area, engaging with selected health systems , key academic centers, specialists, primary care providers, and other stakeholders.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to provide statistical programming technical support related to R programming, R related system and technology. Develop and drive R programming, package, and ... as R programming SME and functional representative of R systems and infrastructure to identify system and...to resolutions of BDM departmental (internal and external) R related analysis and programming technical issues and difficulties. Lead… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
