- Merck & Co. (Durham, NC)
- 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 ... This role will provide end-to-end support of manufacturing science and technology for commercial vaccine products including Drug Substance, Drug Product, and… more
- Merck & Co. (Rahway, NJ)
- … compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical and programs decisions through the development ... Medical Devices, Product Commercialization, Quality Management System Improvement, Regulatory Compliance , Regulatory Inspections, Social Collaboration, Strategic Leadership, Technology… more
- Merck & Co. (North Wales, PA)
- … compliance processes, and leading high-impact cross-functional teams.Responsible to lead or support-complex technical projects and/or equipment technology ... strategic acumen, and execution, along with leadership skills to lead complex cross functional projects.Essential Duties and Responsibilities:The engineer will… 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. (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 be responsible and accountable for subject matter...for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics… more
- Merck & Co. (Durham, NC)
- 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 ... This role will provide end-to-end support of manufacturing science and technology for commercial vaccine products including Drug Substance, Drug Product, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and ... 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …combines deep expertise in CAR-T process technologies with a strong focus on compliance auditing, risk assessment, and continuous improvement.The Compliance ... lead investigations to ensure process integrity and GMP compliance . Additionally, the role includes overseeing and enhancing manufacturing standards,… more
- Merck & Co. (Rahway, NJ)
- …GCP Guidelines, Management Process, Medical Writing, Process Improvements, Regulatory Compliance , Risk Management, Social Collaboration, Strategic Planning, ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM...`quality by design` within clinical development programs, using a risk -based approach.The incumbent will be accountable for the overall… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams on key milestones relating to the tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance of signal tool and support ... the material content of any documents sent to regulatory authorities. Provides compliance metrics to management, as needed. Lead continuous improvement around… more
- Merck & Co. (Rahway, NJ)
- …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 ... and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images… more
- Merck & Co. (Rahway, NJ)
- … compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical and programs decisions through the development ... a key leadership role within the Device Development and Technology Organization. This position is responsible for providing strategic...syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process for reviewing and assessing ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… more
- Merck & Co. (Rahway, NJ)
- …strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence ... and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise wide… more
- Merck & Co. (Rahway, NJ)
- …cross-modality technical team. As an individual contributor, the associate director will lead cross functional teams.- The leader will be responsible for executing ... and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images… 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 ... optimization and provide dedicated engineering expertise related to new process/ technology integration and facility expansion initiatives.Key Responsibilities This individual's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …culture of collaboration, innovation, and continuous improvement within the team. Compliance and Risk Management:Proactively identify potential regulatory risks ... risk assessments and provide actionable recommendations to mitigate compliance risks.Provide training and guidance to internal teams on regulatory requirements… more
- Merck & Co. (Rahway, NJ)
- …will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), participating in ... risk assessments, and Good Documentation Practices (GDPs).-In addition to...Head of the Crystallization Lab, the principal scientist may lead strategic technical initiatives and support talent development of… more
- Merck & Co. (Rahway, NJ)
- …pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing sites, ... large multifaceted projects as the leader of a cross-functional team.--Champion compliance and safety; promote a culture of diversity, inclusion, and equity.Champion… 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 ... the incumbent may be expected to serve as Program level Delivery Lead on large and/or complex programs, including those involving co-development (Alliance) partners.… more
