- Merck & Co. (North Wales, PA)
- …global human health. This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership ... of one or more projects.-- Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual… more
- Merck & Co. (Rahway, NJ)
- …the technical process leadership and laboratory capabilities in support of late -stage pipeline and post-market commercial manufacturing processes for vaccines and ... in conjunction with internal and external partners, this individual will support late stage and commercial large molecule program activities within CCFS. The… more
- Merck & Co. (Rahway, NJ)
- …principles applicable to the pharmaceutical industry.Primary Responsibilities:Leads late -stage development for multiple Metabolism projects, including pipeline ... functional experts across the enterprise to ensure operational excellence in the late development of assets within the Metabolism Section of Global Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late -Stage Development Portfolio. The individual will play a key role in making ... supporting CDx submissions to the FDA and other health authorities globallyFor late -stage programs, executes the Diagnostic development strategy for a project under… more
- Merck & Co. (Rahway, NJ)
- …of experimental plans and data analysis Support both early and late -stage development candidates, including screening and development of robust drug product ... -Experienced in biologics process development and characterization particularly for late stage programsCapable of leading formulation development activities in… more
- Merck & Co. (Rahway, NJ)
- …across functions to drive defined milestones.Support both early and late -stage development candidates that will include ensuring screening and development ... of critical attributes, and technology transfer of early phase and/or late phase drug product manufacturing processes to GMP production facilities.Experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late -stage project or act as main CMC Lead of an early-stage project. He/she has ... coordination and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position serves as the Clinical Safety Scientist Lead for a large, late -stage program or multiple early-stage programs, in order to proactively perform safety ... position serves as the Clinical Safety Scientist Lead for a large, late -stage program or multiple early-stage programs, in order to proactively perform safety… more
- Merck & Co. (Rahway, NJ)
- …relevant experience; BS with 14+ years of relevant experience.Experience in late -stage development, including development, validation and/or transfer of methods for ... thinking/risk taking and eliminates obstacles to implement change.-Experience in late -stage development, including API attributes definition, solid-state methods development,… more
- Merck & Co. (Rahway, NJ)
- …execution of experimental plans and data analysisSupport both early and late -stage development candidates, including screening and development of robust drug product ... -Experienced in biologics process development and characterization particularly for late stage programsCapable of leading formulation development activities in… more
- Merck & Co. (Rahway, NJ)
- …and engineers to advance the biologics pipeline from early- to late -stage development.Partner with groups in both research and manufacturing divisionsRepresent your ... functional area in cross-functional teams. Coaching and Mentoring Train and mentor junior scientists in experimental design, execution, and data interpretation Safety and Compliance Contribute to a safe and compliant laboratory work environment.MINIMUM… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity ... including post marketing projects and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position… more
- Aequor (Bothell, WA)
- …processes for recombinant proteins and biological macromolecules for early- and late -phase clinical trials. The responsibilities of this position include but are ... not limited to designing and executing bench-scale development and characterization studies with proper documentation, analyzing and interpreting results, and authoring technical reports. This position interacts and collaborates with fellow scientists within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …an understanding of lifecycle management and plan for strategy and execution. Occasional early/ late meetings to communicate real time with other time zones such as ... Japan. Education/Experience: o Express an interest in Leadership and Global Research and Development Drug Processes. Prior experience in project management or project management software such as MS Project is a plus.o Ability to effectively manage multiple… more
- Merck & Co. (Rahway, NJ)
- …EDSA leads a large investigator-initiated studies program in partnership with late -stage development teams in Medical Affairs while also supporting early-stage ... development teams. The role also partners with Medical Affairs leadership to develop the global Value Evidence and Medical (VEAM) Planning strategy across designated therapeutic areas.The EDSA has a key role at major Congresses, including, but not limited to,… more
- Merck & Co. (Rahway, NJ)
- …members to design and develop robust processes in support of early- and late -stage biologics. You will innovate to support our company's biologics pipeline and ... production platforms through rigorous scientific principles. You will have the opportunity to apply and integrate innovation into biologic process sciences to establish our company as the industry leader in next-generation biologics manufacturing.- You may… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Having knowledge of all phases of drug development, including early and late phase clinical development and submission preferred- Having solid background of applied ... statistics preferred- Solid knowledge of new advanced statistical methods using SAS preferred- Knowledge in database structures and set-up preferred- The candidate should have successfully provided programming expertise at the Project level for at least two… more
- Merck & Co. (Rahway, NJ)
- …and develop downstream purification processes in support of early and late -stage biological products.-- The scope and activities include designing and optimization ... of downstream unit operations such as cell harvest, filtration, chromatography, viral clearance, precipitation, crystallization, and continuous processing for batch and intensified/continuous bioprocesses.- The role will also include strategic Applicants… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and serves as ad hoc member to the Global Project Team for late stage projects. This position manages multiple biological developmental projects with supervision, ... including working with contract manufacturing organizations CMO. This position develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB)… more
- Merck & Co. (Rahway, NJ)
- …fit-for-purpose assay validation.Interface with scientists and physicians in early and late -stage clinical development to execute on biomarker strategies in clinical ... trials.Writing memos, final reports and publications summarizing data, and writing/updating lab SOPs.Serve as a subject matter expert in mass spectrometry-based assay development and validation, collaborating with project teams, biomarker leaders, clinical… more
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