- Merck & Co. (Rahway, NJ)
- …delivery product design and delivery device technologies, including the design requirements of the associated primary container systems .Strong external ... & Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug / vaccine - device enabled combination products to achieve safe and… more
- Merck & Co. (Rahway, NJ)
- …DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & ... Technology (DD&T) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and effective delivery… more
- Merck & Co. (Rahway, NJ)
- …to high-volume clinical and commercial assembly equipment and processes for medical devices/ drug delivery systems . Reporting to the Director responsible for this ... develop robust assembly specifications with sound justification.Understand medical device/delivery system product design , functionality, storage, and handling… more
- Merck & Co. (Rahway, NJ)
- …software development, pharmaceutical sciences, bioinformatics, target discovery, quantitative systems pharmacology, model-based drug development (MBDD), or ... License:NoHazardous Material(s):n/aRequired Skills:Agile Application Development, Asset Management, Benefits Management, Drug Discovery Process, Management System Development, Pharmaceutical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cross-functionally across Technical Operations and interface with IT to drive the design and implementation of new system updates for cell therapy ... will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at… more
- Formation Bio (New York, NY)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Formation Bio (New York, NY)
- …who thrives on technical depth, mentorship, and platform thinking. You'll lead the design of scalable systems that transform both structured and unstructured ... is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more… more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... in the CDTProvide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniquesRepresent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... curriculum in areas of general use, foundational and core skills, systems , unit operations and aseptic processingPrepares and maintains training lab, materials… more
- Merck & Co. (Rahway, NJ)
- …Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant impact in ... forefront of innovation in the-Manufacturing Division, specifically within the-Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification-department is… more
- Merck & Co. (North Wales, PA)
- …to meet the value evidence needs of payers, advisory committees health systems , and clinicians.The incumbent can generate these plans based on direct interactions ... HTA/reimbursement needs for the product and gain input on research design and implementation of retrospective database studies, assessment of patient reported… more
- Eisai, Inc (Exton, PA)
- …focused on the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate (ADI) production ... knowledge on industry best practices and emerging trends.8. Oversee design , implementation, and commissioning of new technologies for manufacturing. Oversight… more
- Merck & Co. (North Wales, PA)
- …statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development ... submissions and post marketing support.The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups… more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... the CDT Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical...plans Perform UAT of Randomization part of the IRT system as applicable Ensure procedures for blinding are in… more
- Merck & Co. (North Wales, PA)
- …responsible for Portfolio Real-world Evidence (RWE) in Oncology.- -Position objectivesTo design and execute real-world evidence studies, designed to demonstrate the ... will support one or more assets, including but not limited to antibody drug conjugate assets for cancer treatment.To support the implementation of RWE capability… more
- Merck & Co. (North Wales, PA)
- …: This position supports statistical programming activities for late stage drug /vaccine clinical development projects. This may include leadership of one or ... and post marketing support. - The incumbant is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which… more
- Eisai, Inc (Nutley, NJ)
- …strategy for global MA/MSL training that is personalized, integrated with Eisai systems , and data-driven.Support new hire MSLs scientific training via didactic and ... (eg medical insights workshops, presentation skills, understanding clinical trial design , statistics, etc.) to supplement MSL development.Collaborate with Digital… more
- Lundbeck (TX)
- …brain health and transform lives. As Lundbeck's North American hub for early-stage drug discovery, the Lundbeck La Jolla Research Center positions our company to ... leads a world-class team researching new understandings of the behavior of biological systems and their interactions with small molecules, in order to populate the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and efficiencies within cell therapy Technical Operations.Support organizational design updates, operations organization build, operations ramp-up of commercial ... and compliance risks.Technology & Automation: Familiarity with modern manufacturing systems (MES, ERP, etc.) and digital transformation initiatives.#Li-BZ1#Li-HybridThe anticipated… more
