- Merck & Co. (Rahway, NJ)
- …Responsibilities:Utilize extensive experience in design controls , device transfer, control strategies, device risk management, and design verification ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership role within the...in managing external partners and suppliers.Proven expertise in design controls , risk analysis, control strategies,… more
- Merck & Co. (Rahway, NJ)
- …science is applied to deliverables for new product introductions and technology transfers across the network.Drive proactive risk management activities, ... Job DescriptionReporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be… more
- Merck & Co. (Durham, NC)
- …industry technical business processes including:- technical documentation, change control , portfolio management, risk mitigation, deviation management, ... Job DescriptionVaccines tech product leadership (V-TPL) within large molecule science and technology (LMS&T) is seeking a highly motivated individual for the role of… more
- Merck & Co. (North Wales, PA)
- …and compliance processes, and leading high-impact cross-functional teams.Responsible to lead or support-complex technical projects and/or equipment technology ... concepts and techniques.Broad experience with devices and combination products, covering design control to product and technology transfer for both new and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development ... (NGB) facility at our company Rahway, NJ site. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role… more
- Merck & Co. (Durham, NC)
- …industry technical business processes such as:- technical documentntation, change control , portfolio management, risk mitigation, deviation management, technical ... Job DescriptionVaccines tech product leadership (V-TPL) within large molecule science and technology (LMS&T) is seeking a highly motivated individual for the role of… more
- Merck & Co. (Rahway, NJ)
- …equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/ validation.Demonstrated ... and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key… more
- Merck & Co. (Rahway, NJ)
- …Expertise: Utilize extensive experience in design controls , device transfer, control strategies device risk management, and design verification testing to ... prefilled syringes, and complex drug delivery systems.Proven expertise in design controls , risk analysis, control strategies, design verification… more
- Merck & Co. (Rahway, NJ)
- …equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/ validation.Demonstrated ... cross-modality technical team. As an individual contributor, the associate director will lead cross functional teams.- The leader will be responsible for executing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and innovate signal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …not limited to IQ/OQ/PQ, EMPQ, APS, PPQ, preferred.Experience with change management/change control and quality systems.Experience with FMEA and risk assessment ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality ... to implement `quality by design` within clinical development programs, using a risk -based approach.The incumbent will be accountable for the overall strategy for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell ... CAR-T process technologies with a strong focus on compliance auditing, risk assessment, and continuous improvement.The Compliance Auditor will conduct internal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell ... Raritan, NJ. Role OverviewThis position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities at the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in… more
- Merck & Co. (Rahway, NJ)
- …and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process ... Control , Manufacturing Scale-Up, Manufacturing Systems, Regulatory Compliance, Results-Oriented, Technology Transfer-Preferred Skills:Job Posting End Date:09/16/2025 *A job posting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell ... and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile… more
- Merck & Co. (Rahway, NJ)
- …include following current Good Manufacturing Practices (cGMPs), participating in risk assessments, and Good Documentation Practices (GDPs).-In addition to supporting ... and/or the Head of the Crystallization Lab, the principal scientist may lead strategic technical initiatives and support talent development of junior engineers.A… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... of the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports,… more
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