- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …playbooks and resources that define LinkedIn governance, content guidelines, community management strategies, and engagement protocols.- Lead the creation of ... technology , healthcare/pharmaceuticals, as well as social media crisis management are preferred preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative… 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)
- …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
- 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)
- …and apply regulatory / compliance requirements relative to design controls and risk management activities. Lead the preparation of materials for ... Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) Team designs, develops, and commercializes novel biologic/drug/vaccine… 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 management Lead Support Corporate, PS AM, local IT, & local...within compliance with a Quality Mindset that focuses on risk management and mitigation. Utilize the appropriate… 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 ... to issues, and demonstrated passion for creating new medicines.Leadership & People Management : Proven ability to lead cross-functional teams, manage performance,… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... Source Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management ). Lead Periodic Business and Operations Review Meetings… 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. (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
- 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
- Aequor (Thousand Oaks, CA)
- …and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management , and leading matrixed teams through influence to meet NPI ... Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital...to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of… 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...pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups,… 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)
- …updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...and Switzerland. CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Strategy, AI Engineering, and IT teams to ensure a strong data and technology foundation. Lead opportunity analyses and business case development using advanced ... Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and statisticians,… more
