- Aequor (East Syracuse, NY)
- …deliverables within given timelines.Ability to problem solve and apply risk -based critical thinking in a technical environment.Demonstrated history of continuous ... ResponsibilitiesPosition SummaryThe Contractor Scientist within the Analytical Science and Technology team is responsible for supporting analytical method lifecycle… 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 ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also… more
- Merck & Co. (Rahway, NJ)
- …is a key leadership role within the Device Development and Technology Organization. This position is responsible for providing strategic leadership, technical ... and technical staff to support global and site-specific projects, facilitate technology transfer, and drive product robustness for sustained launch in alignment… 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 ... of GxP audits assigned in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned with the company's strategy and… 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
- 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
- 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
- Merck & Co. (Durham, NC)
- … Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer, Develop and Execute Manufacturing Process Robustness Plans, Production ... Meetings (with External Partner).-- Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management,… more
- Merck & Co. (Rahway, NJ)
- …Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) Team designs, develops, and commercializes novel biologic/drug/vaccine ... apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program presentations for… 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 ... the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our… 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 ... the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our… 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...promote fast and efficient closure.As needed, safely perform High Risk Work involving hazardous energy control.Identify and follow through… 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
- Novo Nordisk Inc. (Durham, NC)
- …SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... within 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
- 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 ... financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management: Ability to identify, assess, and mitigate operational and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enterprise technologies and will also be responsible for performing technical risk and vulnerability assessments at the network, system, and application level. ... responsibilities developing and implementing security controls and formulating operational risk mitigations. Relationships: Reports directly to the manager of Global… 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
- 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 updating policies, monitoring trends and working cross-functionally to ensure the risk to Daiichi Sankyo is minimized.- DAIICHI SANKYO SOCIAL MEDIA FORUM-… 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 ... its partners as applicable ensuring the execution of a risk -based audit program and effective CAPA management resulting from...in alignment with the Master Audit Schedule, using a risk -based approach to ensure the Audit Plans are aligned… more
