- Citigroup, Inc. (Wilmington, DE)
- …resource allocation. Risk & Compliance Focus: Ensure that all credit risk technology programs are aligned with the organization's risk appetite, ... on time, within scope, and on budget. Partner with senior leadership in risk , technology , operations, and compliance to align technology investments with… more
- Merck & Co. (Rahway, NJ)
- …& Process Development (DPPD) Team within our Device Development & Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug/ vaccine ... experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well… more
- Merck & Co. (Rahway, NJ)
- …space, including process flow diagrams & engineering drawingsProcess development and technology transfer experience including the use of risk assessment ... as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.The… more
- Merck & Co. (Rahway, NJ)
- … compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical and programs decisions through the development ... is a key leadership role within the Device Development and Technology Organization. This position is responsible for providing strategic leadership, technical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Chemical Commercialization Technology (CCT) department, which is part of our Manufacturing Division , is seeking self-motivated individuals who ... develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects… more
- Merck & Co. (Durham, NC)
- …Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance :-Achieve compliance goals through a risk -based approach ... Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer, Develop and Execute Manufacturing Process Robustness Plans, Production… more
- Merck & Co. (Rahway, NJ)
- …within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management ... Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) Team designs, develops, and commercializes novel biologic/drug/vaccine… more
- Merck & Co. (Rahway, NJ)
- …of manufacturing GMP 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
- Aequor (Thousand Oaks, CA)
- …identify areas for improvement in line with ICH E6 (R3), utilising technology to streamline efficiencies and reduce hand offs. Collaborate with cross-functional ... stats programming, TA) to optimize trial delivery. Deep understanding of Risk Based approaches and its impact with Data Management/Site monitoring operationally… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management, and compliance in vendor agreements. Ability to work ... 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 ... rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function… 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 ... comply with legal, regulatory, and corporate standards.- Collaborate with legal, compliance , and other internal stakeholders to ensure that LinkedIn practices are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Management: Ability to identify, assess, and mitigate operational and compliance risks. Technology & Automation: Familiarity with modern manufacturing systems ... 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. (San Francisco, CA)
- …ensure successful implementation of project plans.- Escalates issues through the risk log and drives problem-solving and resolution within the team.Operating Model ... development or manufacturing, including process or analytical development, characterization, technology transfer, validation/PPQ, commercial manufacturing, and process and plant… 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
- Novo Nordisk Inc. (Durham, NC)
- …operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change management ... compliance with a Quality Mindset that focuses on risk management and mitigation. Utilize the appropriate cLEAN® tools...university required May consider an Associate's Degree in Engineering Technology or a relevant field of study from an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit activities per audit program of… more
- Merck & Co. (Rahway, NJ)
- …(BPR&D) organization is responsible for designing and implementing novel bioprocess technology platforms and processes for upstream and downstream processes that ... network internally and will advance a culture of scientific excellence and compliance with our company's procedures for recording time, data entry, and trainings.… more
- Aequor (Thousand Oaks, CA)
- …team at ATO B20. The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20 ... DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills. The… 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 ... Out of Tolerance (OOT) situations and other technical documentationConducts basic risk mitigation options and advanced troubleshooting to identify root cause and… more
