- Merck & Co. (Durham, NC)
- …a successful Validation support of the vaccine manufacturing facilities.The Associate Director , Validation will be responsible for providing Validation ... team within the Technical Operations organization.Position Responsibilities: Reporting to the Director , Validation the incumbent will lead the team of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... Operations for the Data Validation and Reporting function by collaborating with internal and...data programming, reporting, data visualizations, external data acquisition and validation , and tools to support project portfolio across drug… more
- Twist BioScience (South San Francisco, CA)
- Director /Sr. Director , Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated ... Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, in-house developed MES solutions… more
- Eisai, Inc (Exton, PA)
- … Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting documentation. ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Associate Director , Clinical Programming must have expertise in addressing technical challenges in the ... skills in SAS systems and application development and experience. The Associate Director must be a highly specialized individual contributor or functional manager… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high ... process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance, and engages stakeholders to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Global Director of Platform Innovation as part of the Technical Operations team based in Raritan, NJ. Role OverviewLegend Biotech is ... seeking a Global Director of Platform Innovation within our Global MSAT organization...financial, and compliance benefits to leadership.Lead or support process validation , regulatory submissions, and regulatory inspection readiness related to… more
- Merck & Co. (Rahway, NJ)
- …motivated and experienced Anatomic Pathologist (MD) for the role of Principal Scientist ( Director ) to join our innovative team. This position will play a crucial ... role in the supporting the development, analytical validation , and testing of histopathology-based assays for clinical implementation and advancing digital pathology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry - Required 4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - ... Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization. This… more
- Merck & Co. (South San Francisco, CA)
- …AI and Genome Sciences (DAGS)-Department is recruiting-an Associate Director , Computational Biology-in-Cardiometabolic Drug-Discovery-Data Sciences. We are seeking ... drug discovery in the cardiometabolic disease space. The Associate Director will inform discovery, translational medicine, companion diagnostics and… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance position is ... writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to Travel (approximately 15%)This… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role within the Device Development and Technology Organization. This position is ... focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Associate Director will collaborate with a team of engineers and technical staff to… more
- Merck & Co. (South San Francisco, CA)
- …Data, AI and Genome Sciences (DAGS). Our department is recruiting a Senior Director , who will serve as the Computational Biology lead for Cardiometabolic Drug ... inform discovery, translational medicine, companion diagnostics and clinical research. The Senior Director will also serve as a strategic partner to our discovery… more
- Merck & Co. (Rahway, NJ)
- …post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Director , Market Intelligence and Portfolio Insights will leverage Competitive Intelligence methodologies ... a high-performing team while ensuring compliance with legal standards. The Director will drive informed decision-making and strategic alignment through actionable… more
- Eisai, Inc (Bethesda, OH)
- …you. The Data Operations Group at Eisai, Inc. is looking for an Director - Data Scientist/Programmer to drive drug development through predictive modeling of disease ... workflows.Data Quality & Consistency: Proficient in establishing and enforcing validation rules to ensure data integrity, consistency, and high-quality standards… more
- Formation Bio (New York, NY)
- …a key role in providing technical leadership for the development, optimization, and validation of drug substance and drug product analytical methods to support the ... technical documents such as test methods, method development reports, validation protocols, validation reports, specification justification reports, retest… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple… more
- Merck & Co. (Rahway, NJ)
- …post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… more
- Repligen (Waltham, MA)
- OverviewThe Quality Control Supervisor will report to the QC Director .Must have understanding and working knowledge with Quality Control principles and concepts such ... and release which include managing analysts' schedules, instrument calibration, validation , PO generation, managing live testing tracker information, cross-functional… more
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