- 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
- Aequor (Thousand Oaks, CA)
- …Deep understanding of Risk Based approaches and its impact with Data Management /Site monitoring operationally - consider the role of both Data Management and ... knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk -based Quality Management etc. Determine key performance indicators (KPIs)… more
- Formation Bio (New York, NY)
- …propensity and eagerness to incorporate AI into their work, leveraging technology to enhance program management efficiency and effectiveness.Responsibilities ... trial operations. About You You're excited about the intersection of AI and program management and eager to explore how technology can streamline and scale… more
- Merck & Co. (Rahway, NJ)
- …experts within the broader DD&T team (eg design verification, device risk management , human factors, technical integration, assembly automation, etc.), ... development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer, Develop and Execute Manufacturing Process Robustness Plans, Production… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop value-added ... technology transfer programs in both development and lifecycle management , ensuring compliance with relevant regulatory standards.Ensure robust technical plans, … more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... space, including process flow diagrams & engineering drawingsProcess development and technology transfer experience including the use of risk assessment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience working and managing ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy… more
- Merck & Co. (Rahway, NJ)
- …-The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. ... Job DescriptionThe Chemical Commercialization Technology (CCT) department, which is part of our Manufacturing Division , is seeking self-motivated individuals who… more
- Merck & Co. (San Francisco, CA)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug… more
- Novo Nordisk Inc. (Durham, NC)
- …and 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...university required May consider an Associate's Degree in Engineering Technology or a relevant field of study from an… 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
- 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)
- …and apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program ... Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) Team designs, develops, and commercializes novel biologic/drug/vaccine… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate ... 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)
- …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
- 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 the Head of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout the course of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … technology , healthcare/pharmaceuticals, as well as social media crisis management are preferred preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative ... 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)
- … Management , Pharmaceutical Process Development, Process Scale Up, Program Risk Management , Project Planning, Protein Characterization {+ 2 more}-Preferred ... (BPR&D) organization is responsible for designing and implementing novel bioprocess technology platforms and processes for upstream and downstream processes that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GxP group and its partners as applicable ensuring the execution of a risk -based audit program and effective CAPA management resulting from audits, health ... of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise...in alignment with the Master Audit Schedule, using a risk -based approach to ensure the Audit Plans are aligned… more
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