- Merck & Co. (North Wales, PA)
- …- Responsibilities : 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …TA Oncology organization. This position will report to the Global Head of Late -Stage Oncology Development. This individual will play a central role in supporting the ... Global Head of Late -Stage Oncology Development in the formation and management of...plan the transition of asset programs from early to late -stage development in coordination with the Early-Stage Oncology Development… more
- Merck & Co. (Rahway, NJ)
- …the technical leadership and laboratory capabilities in support of late -stage pipeline commercialization and post-market commercial manufacturing support. BDSC ... conjunction with internal and external partners, this individual will support late stage and commercial large molecule biologics program activities. The individual… more
- Merck & Co. (Rahway, NJ)
- …the technical leadership and laboratory capabilities in support of late -stage pipeline commercialization and post-market commercial manufacturing support. BDSC ... conjunction with internal and external partners, this individual will support late stage and commercial large molecule biologics program activities. The individual… more
- Merck & Co. (Rahway, NJ)
- …across functions to drive defined milestones.Support both early and late -stage development candidates, including screening and development of robust drug ... of critical attributes, and technology transfer of early phase and/or late phase drug product manufacturing processes to GMP production facilities.Experience… more
- Merck & Co. (Rahway, NJ)
- …related to next generation processing for assets in early- and late -stage clinical development. Applicants must have effective organizational and multi-tasking ... processes including intensified inoculum and perfusion process development.Experience with late -stage commercial process development, technology transfer, scale-down model qualification… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process characterization efforts, and critical parameter definition for late -stage and commercial manufacturing.Develop technology and process platform ... roadmapsDevelop key event milestones as part of project planning / oversight in support of tech transfer activitiesDrive cross-functional collaboration with Site MSAT, Manufacturing Operations, Quality, Process Development, and Regulatory to facilitate… more
- Merck & Co. (Rahway, NJ)
- …in this role, you will serve as the translational lead on late -stage immunology programs, driving the Precision Medicine objectives in alignment with clinical ... development plans. Collaborating with Discovery, Translational Medicine and Product Development Teams, you will be the authority in defining and interpreting the translational experiments and data generated respectively from our clinical trials, and… more
- Merck & Co. (Rahway, NJ)
- …pathology algorithms.Interface with scientists and physicians in early and late -stage clinical development to execute histopathology-based biomarker strategies in ... clinical trials.Establish new histopathology-based assays in the laboratory as part of a team.Provide subject matter of expert pathologist input to discussions in a highly matrixed environment, collaborating with internal and external stakeholders.Position… more
- Merck & Co. (Boston, MA)
- …post-licensure). The Senior Director will manage the entire cycle of late -stage clinical development and studies, including development strategy, study design, ... initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and… more
- Eisai, Inc (NJ)
- …reports to Market Access and Medical Affairs and primarily focuses on late -stage pipeline and marketed products The role interfaces with cross functional teams ... and manages the HEOR field team in customer research activities and development of external communication materials. The Sr. Director facilitates coverage, reimbursement, and appropriate utilization based on generation and communication of quality… more
- BioAgilytix (Boston, MA)
- …proactively informing Customer Service of any issues which may cause late results.Performing and documenting routine equipment use, maintenance, calibration as well ... as routine, scheduled, and unscheduled preventive maintenance.Participating in method development and equipment qualification activities as directed by Laboratory Management.Supporting audits, inspections, and assisting in responding to observations, if… more
- Merck & Co. (Rahway, NJ)
- …related to downstream processing for drug candidates in both early and late -stage development.Responsibilities include, but are not limited to:Serve as a scientific ... leader to shape and drive innovation across the Biologics pipeline, strategy, and science.Anticipate and solve scientific and technical challenges across projects and functional teams, in a fast-paced, multidisciplinary environment.Lead the development of… more
- Merck & Co. (Rahway, NJ)
- …to upstream processing and recombinant expression of drug candidates in early- and late -stage development .- Responsibilities include but are not limited to: As an ... impactful contributor, shape and realize innovation across the Biologics' pipeline, strategy, and scienceAdvance the pipeline by collaborating with cross-functional teams, from Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate… more
- Merck & Co. (Rahway, NJ)
- …processing and recombinant expression of drug candidates in early- and late -stage development.Responsibilities include, but are not limited to:Serve as a scientific ... leader to shape and drive innovation across the Biologics pipeline, strategy, and science.Anticipate and solve scientific and technical challenges across projects and functional teams, in a fast-paced, multidisciplinary environment.Lead the development of… more
- Aequor (Framingham, MA)
- …robust and scalable purification processes to support 2nd generation processes, late -stage programs, and life-cycle management. This position will support the ... development of purification processes for a wide variety of molecules and modalities. In concert with 's Patient First philosophy, this role will play a key role in developing robust and scalable protein purification processes to deliver to the manufacturing… more
- Eisai, Inc (Exton, PA)
- …material for toxicology and phase I to III studies), and in the late -stage processes at CMOs that support the company's clinical development pipeline. The individual ... contributes to the success of the organization by providing seasoned organizational leadership and deep scientific, engineering, and operations knowledge. Specifically, this person will contribute to the success of the operation by ensuring the development,… more
- Merck & Co. (North Wales, PA)
- …position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical development 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 clinical trials to world-wide regulatory application… 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)
- …steps during the manufacturing of biologics to support their early- and late -stage CMC development. Other responsibilities may include the development of custom host ... cell protein (HCP) reagents and highly sensitive immunoassays to monitor the clearance of problematic residual host cell proteins that may impact product safety, efficacy, and stability. The qualified candidate is expected to be a leader in new technology… more
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