- Genmab (NJ)
- …like a fit? Then we would love to have you join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as ... responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... compliance mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) ... with device design, requirement management, FMEA, design verification, design validation , statistical sampling, and control strategyExperience with regulatory fillingsWorking… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant ... Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You'll design experiments, analyze data, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for Cell/Gene… more
- Insmed Incorporated (San Diego, CA)
- …on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of the ... and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …handling, lead the statistical support in safety signal detection, validation , characterization and reporting in collaboration with safety programming team, ... CSPV, and epidemiology for several projects with minimal direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety signal monitoring for ongoing trials.Safety analysis… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionAs AD/ Director of Data Science - Platform at Formation Bio, you will lead one ... strategies Foster a culture of rapid execution while maintaining rigorous validation standards About YouRequired Qualifications PhD in computational sciences or life… more
- Twist BioScience (South San Francisco, CA)
- 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 across our… 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
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... will be based in Waltham, MA and will report to the Sr. Director , Quality - Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director ,… more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... the broad guidance of the DSCS Digital Program Mgmt Lead, the Associate Director , DSCS Digital Project Manager, will be responsible for implementing improved project… 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)
- …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
- 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. (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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director HVAC : The HVAC Associate Director is responsible for leading and developing a team that supports HVAC operations and system ... candidate will have strong technical expertise in HVAC design, maintenance, and validation within a highly regulated environment, combined with leadership skills to… more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... familiar with using statistical software for design of experiments.Experience with qualification, validation , and transfer of assays to a GLP or regulated laboratory… more
- Merck & Co. (Rahway, NJ)
- …equipment and processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in medical device assembly ... Design, Mechanical Testing, Medical Device Manufacturing, Medical Devices, Method Validation , Operational Acceptance Testing (OAT), Product Development, Prototyping, Social… more