- Insmed Incorporated (NJ)
- …also involve developing outstanding program management skills, attention to business details, and strong critical thinking abilities within the team. ... documentation - Target Product Profile, Integrated Development plans, Dashboards, Risk assessments and other key tools to improve organizational processes.Challenge… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... detect critical flaws including ability to determine areas of potential risk , generate gap analysis and mitigation strategiesIn-depth knowledge of global regulatory… more
- Eisai, Inc (NJ)
- …teams and external partners, the Director drives operational excellence, risk mitigation, and inspection readiness while fostering cross-functional collaboration and ... strategies that achieve cost efficiencies, improve vendor performance, and minimize risk .Manages vendor qualification processes and partner with Vendor Risk … more
- Merck & Co. (Rahway, NJ)
- …strategic and tactical technical direction through cross-functional partnerships with key business units and customers.-- Your leadership will be instrumental in ... documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance… more
- Merck & Co. (Millsboro, DE)
- …on-time, on-budget delivery and compliant, unconstrained supply that supports business growth. You will provide strategic oversight, standardized methodology, and ... lead own timely execution of transfer strategies across Blocks 2-6, balancing speed, risk , and complianceServe as the single point of contact across donor and… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and ... design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation,… more
- Repligen (Waltham, MA)
- …digital systems. This role drives the ITGC audit program, advises on risk mitigation strategies, and partners closely with Internal Audit, IT, Financial Reporting, ... ensure "controls by design."Maintain ITGC narratives, process flows, and risk /control matrices.Identify and drive process improvements, automation opportunities, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other ... on clinical trial execution. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic,… more
- Syner-G BioPharma Group (Boston, MA)
- …commissioning and qualification of facilities, utilities, and equipment (FUE).Assist with risk assessments, feasibility reviews, risk mitigations, and testing of ... for improvement projects regarding processes and systems.Support or provide risk assessment and mitigation activities for process development, manufacturing, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management strategies to uncover strategic insights to help influence and inform Business decisions. Proactively seeks out and recommends new process improvements to ... from vendor assessment, RFP, negotiation, award and contracting with senior business stakeholders for DS products and alliances.- Develops comprehensive global… more
