- Legend Biotech USA, Inc. (Raritan, NJ)
- …of 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...assurance, manufacturing compliance, clinical quality, or cell therapy.GxP Quality System knowledge, including relevant regulations and guidances (eg 21… more
- Merck & Co. (Rahway, NJ)
- …and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work ... Engineering Leaders, assisting them in navigating their development programs.Primary Responsibilities: Lead and set direction for the device development strategy for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global systems , electronic records, validation… more
- BioAgilytix (Durham, NC)
- …processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement ... for centralized data storage.Create APIs to enable real-time data sharing between systems , with a focus on operational efficiency and data integrity. Data Quality… more
- Aequor (Devers, TX)
- …pricing, vendor IDs, UPOM, AUOM, etc. Vendor Setup: Manage vendor setup from one ERP System to another ERP Systems (ie, Oracle to SAP). Dual Sourcing Setup: When ... Months with High Possibilities of ExtensionDescriptionThe Cell Therapy SAP Sourcing Migration Lead is located in Devens, Massachusetts. This role will report to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programming in DS external collaborations on R technology and capabilities.Responsibilities:- Lead /contribute to DS R programming system technology development: ... Lead /contribute to the R programming system development. Act as R programming SME and functional...as R programming SME and functional representative of R systems and infrastructure to identify system and… more
- Merck & Co. (Rahway, NJ)
- …The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The ... and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute… more
- Merck & Co. (Rahway, NJ)
- …techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop ... improve performance.Apply technical skills and ingenuity to correct equipment and system problems that result in downtime or consume excessive maintenance resources… more
- Novo Nordisk Inc. (Durham, NC)
- … systems and associated applications required Proven expertise in system interfacing and integration required Experience in Project Management, Batch Reporting, ... us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical...development & initiative to understand the site process control systems , data management systems , and differing data… more
- Twist BioScience (South San Francisco, CA)
- …DescriptionWe are seeking an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, ... system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS, QMS) using… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical...assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for… more
- Eisai, Inc (Indianapolis, IN)
- …hear from you. The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and manage a team of sales professionals. The ... (S-suite, C-suite, KOLs, Pathway and PandT committee members). Each ABL will lead account responsibility for a defined number of potential strategic accounts and… 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 ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Merck & Co. (Durham, NC)
- …problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review and approve out of tolerance (OOT) records ... Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved vendors for calibrations not performed by site… more
- Merck & Co. (Durham, NC)
- …to focus instrument performance and minimize downtime.Initiate and complete SOP revisions. Lead 8-step problem solving sessions to support investigations and develop ... appropriate CAPAs which lead to program improvements.Review and approve out of tolerance...Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved vendors for calibrations not performed by… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of IT security strategy and serving as a security advisor to ensure IT systems are implemented and maintained to the highest security standards. Individuals in this ... for performing technical risk and vulnerability assessments at the network, system , and application level. Some responsibilities developing and implementing security… more
- Aequor (Thousand Oaks, CA)
- …change the world. In this pivotal role, you will report to the Planning Lead within the Global Supply Chain Organization and will be accountable to deliver strong ... of network initiatives to drive improvements in Supply Chain processes, systems , and procedures. Interfaces across functions including Supply Chain, Manufacturing,… more
- Repligen (Rancho Dominguez, CA)
- …Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation, and ... are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at… more
- Repligen (Clifton Park, NY)
- …the tools and techniques of Lean Manufacturing and incorporate it into the culture. Lead the implementation of the Repligen Performance System (RPS) throughout ... single-use state-of-the-art single use components and innovative storage and transfer systems that optimize fluid transfer and reduces the number of connections… more
- Merck & Co. (Rahway, NJ)
- …agent for our order-to-cash process. This role offers the opportunity to lead and execute key projects and change initiatives within Order Management, Customer ... acquired companies into our platforms and processes. Handle small projects as a lead analyst, project manager, or as the subject matter expert. Account and manage… more
