- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process optimization to deliver measurable results through the engagement in design and develop methodologies, pursuing the implementation of projects and monitoring ... to develop and execute strategies to enhance quality processes and systems organization-wide. Identify and implement best practices for process improvement and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members, periodic review of user access and audit trail reconciliation, impact analysis and documentation of identified access discrepancies per study to maintain ... Clinical Trial experience in the device/pharmaceutical/CRO industry required.Expertise in CDR systems including best practices of data security, role & security… more
- Merck & Co. (Rahway, NJ)
- …Are you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our company's Device ... & Process Development (DPPD) Team, which focuses on the design , development, and commercialization of novel biologic/drug/vaccine-device combination products for… more
- Formation Bio (New York, NY)
- …Strategic and creative thinker, strong leader, and subject matter expert in pharmaceutical quality systems with the ability to design and implement a 'fit for ... in quality management tools and methodologies (eg, risk assessment, root cause analysis , FMEA) and quality management software systems . Strong organizational… more
- Tris Pharma (Monmouth Junction, NJ)
- …Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, oversees ... and Drug Administration (FDA) standards and batch record specifications.The incumbent uses systems thinking and a holistic systems -based approach to drive… more
- Merck & Co. (Rahway, NJ)
- …ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA's) for all finished product performance test ... and functional properties and attributes. This understanding, combined with extensive data analysis /interpretation, will allow the role to design and develop… more
- Merck & Co. (Rahway, NJ)
- …ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA's) for all finished product performance test ... and functional properties and attributes. This understanding, combined with extensive data analysis /interpretation, will allow the role to design and develop… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for providing engineering support for building automation and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. ... issues, deviations, corrections, remediation and improvement efforts of automation and controls systems for facility, equipment, systems and processes in support… more
- Merck & Co. (Rahway, NJ)
- …in medical device, pharmaceutical or in biotech organizations Five plus years in design control, risk analysis and change control management for medical device ... systems and associated prefilled syringe components- Experience with design verification testing- Experience in working with medical device suppliers- Experience… more
- Merck & Co. (Rahway, NJ)
- …infrastructure, quality, vendors in building, optimizing, and troubleshooting the OT automation systems .The primary location of this position is Rahway, NJ or West ... person for changes to these rules, and evaluation of impact to automation systems with IT driven firewall rule changes.Lead/assist project scopes, define IT and… more
- Merck & Co. (Rahway, NJ)
- …the life of the project, tries to resolve problems during the design and planning phases whenever possible.Provides timely and accurate information and status ... the fieldExpertise in independently conducting and directing the planning, execution, analysis , and documentation of all stages of cell culture process… more
- Merck & Co. (Rahway, NJ)
- … and execute hands-on lab and/or in silico experiments.Proficiency with statistical design and analysis toolsExcellent communication skills, ability to work in ... challenging problems related to developing robust, cost-effective processes. Experimental Design and Problem-Solving Develop and characterize robust processes for… more
- Merck & Co. (Rahway, NJ)
- …will work with a highly collaborative team of Scientists and Engineers to design and develop downstream purification processes in support of early and late-stage ... for recombinant protein purification unit operations. Proven ability to design and execute protein purification experiments independently.Ability to direct the… more
- Merck & Co. (Rahway, NJ)
- …the candidate will utilize Quality Risk Management methodologies and statistical design of experiment tools to ensure robust manufacturing. The scientist is ... lab-based research and process development with high throughput bioreactor systems , benchtop scale bioreactors, and/or production scale bioreactors.Experience with… more
- Merck & Co. (Rahway, NJ)
- …on portfolio or scientific prioritiesEvaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support emerging capabilitiesResponsible ... in pharmacometrics (eg, population PK and PK/PD analyses, model-based meta- analysis , dose-response and exposure-response analyses, disease modeling, trial simulation,… more
- Merck & Co. (Rahway, NJ)
- …experience with applications of pharmacometrics methods. Skills in experimental design , mathematical problem solving, critical data analysis /interpretation, and ... exposure-response models, clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling, thereby strengthening pharmacometrics… more
- Formation Bio (New York, NY)
- …in quality management tools and methodologies (eg, risk assessment, root cause analysis , FMEA) and quality management software systems . Veev experience ... specification development, investigational product manufacturing/packaging and release, stability program design and execution, change management processes, vendor selection and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including RFP development, due diligence on partner selection, study protocol design , analytic plan development, oversight of data collection/acquisition, data ... analysis , and development of research findings into publications in...focus on pharmaceutical research Strong knowledge of health care systems in the US, real-world data sources and analytical… more
- Genmab (Plainsboro, NJ)
- …as well as a deep understanding of US / EU /Japan regional healthcare systems , payer preferences, and market dynamics to lead the market access and pricing launch ... to meet the needs of global payers (eg, relevant endpoints, trial design , sub-populations, evidence of cost offsets) by incorporating HTA and payers' perspectives… more
- BAE Systems (Wayne, NJ)
- …Other incentives may be available based on position level and/or job specifics. ** Systems Engineer - Analysis , Design , Modeling and Simulation** **110199BR** ... **Job Description** Ready to make a difference? Our employees design , integrate, and test the world s next generation... of simulation or flight test results + Requirements analysis Employee Benefits: At BAE Systems , we… more
