- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partners to ensure that deliverables are met according to agreed timelines and quality standards. Lead a team of professionals specializing in ... analytics, testing, and integration, to ensure cohesive and comprehensive service delivery. The lead will provide technical leadership, guiding the team in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to successful approval of ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of PJ Lead and Tech Unit.- Provides leadership in the project/development team , as Matrix Lead , interfacing with various site locations globally and on ... research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and… more
- Merck & Co. (Rahway, NJ)
- …development, and validationSelf-motivated with ability to work independentlyProven ability to lead team members of diverse skill sets and backgroundsStrong ... medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.--… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensure alignment of HCP brand objectives, KOL engagements, and strategies. The HCP - Strategy Lead (MASH) has a team of HCP and KOL strategists reporting to ... based on real-world results. We are building an intentional team culture that is made up of diverse skillsets,...experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Merck & Co. (North Wales, PA)
- …or post-market commercial manufacturing vaccines and biologics. - Technical scope: Lead the hands-on execution of upstream pilot-scale experiments. Typical unit ... monitoring (eg, statistical process control (SPC) and/or multivariate analyses (MVA). Lead technical investigations and process changes that drive improvements to… more
- Merck & Co. (South San Francisco, CA)
- …experience in complex cellular model/assay development, mechanistic pharmacology, and lead discovery support to join our Quantitative Biosciences (Pharmacology) ... early drug discovery projects. The candidate will work closely with a team of multidisciplinary quantitative scientists and other stakeholders to enable strategies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …through business development efforts in existing and new areas. The STARS team collaborates and partners with groups across NAO, Research & Early Development, ... on shaping our future. The Position The Ecosystem & Enterprise Influence Lead is responsible for driving strategic initiatives to address the complex challenges… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma.Legend Biotech is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control ... Lead role is an exempt level position with responsibilities...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Drive continuous improvement.Have advanced computer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Global RD/PV QA team .RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs) by ... on assigned programs and in close collaboration with R&D Quality team members to ensure that the...a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality… more
- Merck & Co. (Durham, NC)
- …Assurance and/or cGMP experienceMinimum of 1 year managerial or team lead experience recommended WORKING RELATIONSHIPS: Reports to Quality Control Associate ... management of all activities required to successfully support the QC laboratory Team to include the following: Quality Manager overseeing analytical testing and… more
- Merck & Co. (Durham, NC)
- …ingredient, finished product, and laboratory testing for the BCG vaccine.The Senior Specialist, Quality Control participates in a team of analysts in the ... for proper resolution to ensure product qualityPROJECT MANAGEMENT: Accountable for quality and/or technical contribution to project team or sub-teamSupport… more
- Twist BioScience (South San Francisco, CA)
- …programs for quality professionals on complaint handling, customer service, and quality metrics.Represent the quality team in cross-functional meetings ... We are seeking a highly experienced and motivated Staff Quality Engineer join our dynamic team . As a Staff Quality Engineer, you will be responsible to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Quality Project Management Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThis position is an exempt ... for identified continuous improvement efforts associated with the manufacturing site. Lead assigned Quality tasks associated with process… more
- Aequor (Thousand Oaks, CA)
- …(R&D, Operations, and GCO). In this vital role you will support the quality management system team to provide proactive compliance oversight to processes, ... System organization. Under general supervision, provide tactical support activities to Quality Management System Lead . Specific responsibilities include but are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process.Monitor clinical trial performance and quality metrics and share with study team , Operations Program Lead , and Sr. Director for the compound, on ... Leadership:Has primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical...solutions, or bring to the attention of the operations lead of study team lead .… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role OverviewThis exempt-level position is ... drug product release practices.Develop positive relationships with the QA team , Quality Control, Information Technology, maintenance, Manufacturing personnel,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and… more
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