- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the Global MSAT team based in Raritan, NJ. Role ... OverviewThe Director of Manufacturing Execution System (MES) will be part of Manufacturing Science and Technology (MSAT) Leadership Team and will be responsible for… more
- Eisai, Inc (New York, NY)
- …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
- 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)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Merck & Co. (Rahway, NJ)
- …is responsible for leading and developing a team that supports HVAC operations and system infrastructure at the Rahway (RY) NJ Campus. - This role ensures HVAC ... systems comply with regulatory standards (eg, FDA, cGMP), maintain...analytics.Establish and monitor key performance indicators (KPIs) for HVAC system reliability, energy efficiency, and compliance.Lead root cause analysis… more
- Eisai, Inc (Exton, PA)
- …to hear from you. Primary responsibility will be to maintain the various control systems throughout the pilot plant facility as well as the laboratory building. The ... control systems include...the appropriate change management mechanisms to improve and verify system function as well as performing preventive maintenance on… more
- Merck & Co. (Durham, NC)
- …and when required calibration activities to ensure applicable equipment and systems are maintained in a compliant state.Maintains the integrity of equipment ... specification data within the computerized calibration and maintenance management system .Troubleshoots equipment and performs necessary repairs. Utilizes various instruments… 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
- Merck & Co. (Rahway, NJ)
- …application designed to create a frictionless flow of data from source systems to regulatory documentation.- Under the guidance of dCMC Leadership, the Senior ... application by identifying, implementing and enforcing data standards from key source systems ; contributing to data model development; and assisting in evolving data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems engineering team. This role will require ... NJ. Role OverviewThe Facility Engineer will be responsible for ensuring equipment/ systems required to support an expanding Cell Therapy facility is appropriately… more
- Twist BioScience (South San Francisco, CA)
- …RoleWe are seeking an experienced Staff Engineer specializing in Salesforce (SFDC) and systems integrations to join our technology team locally at the South San ... product lines and deep understanding of integration to eCommerce and ERP systems to ensure scalable, robust, and flexible cross-functional solutions that support our… 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
- Merck & Co. (Boston, MA)
- …Development, Stakeholder Engagement, Stakeholder Relationship Management, Strategic Planning, System Designs, Systems Development Lifecycle (SDLC)Preferred ... of tools within our Company's ecosystem and with upstream/downstream systems .Apply industry standards and ontologies to develop FAIR (Findable, Accessible,… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The associate director will be a technical subject matter expert on the ... global and site-specific projects related to combination products and drug delivery systems .Ensure that all activities are conducted with the highest regard for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi Sankyo's GxP group.Together with regional ... management teams plans, will support, conducts and reports internal systems and process audits across the organization as appropriate for the area of GxP audits… more
- Merck & Co. (North Wales, PA)
- …and manipulation; experience with sampling strategies for large databasesUnix operating system experience; SQL experience; systems and database experienceThrives ... including data processing, statistical procedures and graphing and tabulation techniques; systems and database expertiseSolid Real World Evidence and Real World… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …MES Engineer will be part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing with MES end users to define ... support the MES team with electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support qualification… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and ... Systems COE the Director, Logistics and Distribution Technology will...for shock and vibration as well as thermal protection system testing and qualification and leading execution of qualification… more
- Eisai, Inc (Nutley, NJ)
- …area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. ... including audit and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice (GCP) oversight, and… more
