- 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
- Eisai, Inc (Indianapolis, IN)
- …If this is your profile, we want to hear from you. The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and ... (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
- Eisai, Inc (Boston, MA)
- …mild cognitive impairment due to Alzheimer's disease (AD) or mild AD. The Area Business Leader (ABL) will lead a team of Neurology Account Specialists (NAS) that ... aspects of Alzheimer's disease and the competitive landscape in which they will lead . Additionally, the ABL will be responsible for ensuring their NASs educate… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Regional Thought Leader Liaison (RTLL), Alzheimer's Disease will lead and execute regional and local ... the Patient JourneyEngage with KOLs affiliated with key regional health systems to understand best practices for establishing diagnostic and treatment algorithmsHelp… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryDeliver the development and implementation of systems and programs to support the business functions of Daiichi Sankyo ... enterprise IT strategy.ResponsibilitiesStrategic Leadership, Platform management and Governance:Implement and lead the global strategy for process automation, RPA, and… 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 ... Francisco, California office. The ideal candidate will serve as a technical leader , driving the architecture and delivery of integration solutions using platforms… 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
- 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
- Aequor (Thousand Oaks, CA)
- …EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will do Let's do this. Let's 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 and agile product leadership… more
- Insmed Incorporated (San Diego, CA)
- …Assurance, the Director of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality ... lead on the gene therapy clinical development team, and...provides support and promotes collaboration internally to ensure all systems , processes and their outcomes comply with applicable international… 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
- 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. (Durham, NC)
- …Durham's Technology Transfer Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for ... technology transfer focusing on either upstream, downstream, and/or culture media/support systems . Off-shift and weekend coverage will be required based on business… more
- Formation Bio (New York, NY)
- …support to cross-functional teams in a matrixed environment. Partner with the Program Leader to support and/or co- lead the program Drive decision-making and ... adapting style to different audiences and simplifying complex information. Lead productive team meetings, fostering collaboration and ensuring clear action… 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
