- 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)
- …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
- 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
- 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
- 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
- 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)
- …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
- 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)
- …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)
- …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
- 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
- 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
- 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
- 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
- City of New York (New York, NY)
- …BE IMMEDIATELY REACHABLE ON EXAM NO. 1133 Under general supervision of the Director of Systems Analysis and Design , (Computer Systems Manager, NM-1), ... of independent initiative and judgment, the Computer Associate (Software) II, functions as Systems Design Analyst is responsible for the analysis design ,… more
- City of New York (New York, NY)
- …maintaining, implementing, and enhancing computer software applications, systems programming, systems analysis and design , data communication software, ... (1) Computer Specialist Software II to function as a Systems Programmer Analyst, who will: - Design ,...imported into the user application database or exported for analysis and used for executive decisions. - Implement metadata… more
- City of New York (New York, NY)
- …maintaining, implementing, and enhancing computer software applications, systems programming, systems analysis and design , data communication software, ... Agency's Enterprise-Wide Area Network. - Diagnose, solve, and deliver root cause analysis for hardware/software issues, analyze and upgrade systems as necessary;… more
