- Merck & Co. (Rahway, NJ)
- …device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position ... applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Merck & Co. (Rahway, NJ)
- …and Plant) within RIPL. -As Sr. OT Infrastructure Specialist, you will lead the definition and implementation of high-level requirements, principles and models that ... services where none exists.- Recommend obsolescence programs for the technology and infrastructure wherever possible.Technical experience in building and maintaining… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Technical Lead will ... knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure...continuously improving. Work with the Data Management and Integration Lead and Process Validation lead on the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from… more
- Merck & Co. (Rahway, NJ)
- …DescriptionJob Description Are you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination ... including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of design verification strategies, and… more
- Merck & Co. (Rahway, NJ)
- Job Description Summary, Focus and Purpose The Senior Engineer in Device Technology is a key member of our Device Development & Technology Team, with ... our Company divisional and local site procedures for safety, quality, and regulatory compliance - Understand the big picture, and how activities link to our Company… more
- Merck & Co. (Rahway, NJ)
- …we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.-The Distinguished ... Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, has primary responsibility for the planning and… more
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practices steps, demonstration of new manufacturing technology /processes, training opportunities for improved manufacturing process development, ... and seamless technology transfer to commercial sites.The SSO Operations Specialist will...hands on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good… more
- Merck & Co. (Rahway, NJ)
- …activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing ... large multifaceted projects as the leader of a cross-functional team.--Champion compliance and safety; promote a culture of diversity, inclusion, and equity.… more
- Formation Bio (New York, NY)
- …controlled documents outside of QA. Assure the execution of QA Audit Plans, Lead internal and external audits to assess compliance with regulatory requirements, ... patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug… 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 ... to collect information, analyze quality related process, define strategies to lead to the development and implementation of quality improvement initiatives across… more
- Merck & Co. (Rahway, NJ)
- …the Biologics formulation team within Sterile Product Development. Primary duties: Lead / contribute towards the new, innovative approaches for biologics sterile ... professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process… more
- Merck & Co. (Rahway, NJ)
- …Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science, and technology , we collaborate to deliver the next medical breakthroughs. ... investments in continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific… more
- Formation Bio (New York, NY)
- …ensure the consistent production of safe, effective, and high-quality pharmaceutical products. Lead internal and external audits to assess compliance with ... patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug… 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 ... primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking an experienced Associate Vice President (AVP) to lead the delivery and operations of our SAP platform, focusing on the S/4 HANA program ... leadership.Develop and implement an SAP enhancement roadmap for efficiency.Influence future technology and talent strategies as part of the Enterprise IT leadership… more
- Formation Bio (New York, NY)
- …patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug ... for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are...that trials are executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage… 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 ... including operating model, SOPs, study resource requirements, and supportive technology (as needed), for the risk-based central monitoring function.Interacts with… 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 ... areas centered around rare diseases and immune disorders. SummaryAccountable to lead , manage and ensure that all Contract Manufacturing, Testing and Warehousing… more
- Merck & Co. (Rahway, NJ)
- …Through innovative thinking, state-of-the-art facilities, cutting-edge science, and technology , we collaborate to deliver the next medical breakthroughs.The ... development, as well as for commercialization and in line commercial projects. Lead development and implementation of robust non-GMP characterization methods, using… more
