- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global sites. These business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral ... Director will influence the strategy, lead activities, and develop a team whose roles include design and development of formulation, manufacturing process,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking Facility Engineer as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for ... facilities engineering support, design, and implementation for mechanical systems and...systems and equipment, and work order management for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will… more
- Merck & Co. (Rahway, NJ)
- …the globe.-You will be part of our Company Research Laboratory Information Technology's Clinical & Real-World Evidence Value team which has presence around the ... Data and Analytics group and Product Lines across the Clinical Value Team . Position will require on...database structure principles, SQL and NoSQL conceptsExperience with Cloud services like AWS and AzureStrong software engineering … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur RaDS IT Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research Automation OT Infrastructure. ... models that guide solution decisions and provide the OT infrastructure "blueprint" for engineering / project teams to implement these solutions.- You will focus on… more
- Merck & Co. (North Wales, PA)
- …This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (North Wales, PA)
- …programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Pharmaceutical Sciences and Clinical Supplies (PSCS) organization translates molecules to medicines, working from the discovery ... and the formulation development of new chemical entities through a matrix team from initial first in human formulations (suspensions, solutions, capsules, tablets)… more
- Merck & Co. (Rahway, NJ)
- …company's biologics pipeline. We work closely with colleagues in Discovery, Pre- clinical and Early Development to rapidly develop manufacturing processes for diverse ... biotherapeutics, and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and the development and… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... Cell Sciences (PCS), Upstream and Downstream Process Development & Engineering . The latter two together form our Biologics' Process...in BPD you will work with a highly collaborative team of scientists and engineers to design, develop and… more
- Merck & Co. (San Diego, CA)
- …of increasingly improved and stable models using relevant biological and clinical datasets.Implement feature engineering engine to identify, extract, evaluate, ... strategies using relevant human data.- You will lead a team of bioinformaticians and data scientists to generate fit...generate novel CDx models that can be deployed in clinical trials. You will also support preparation of regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …HVAC Automation & Controls Technician (Contractor) as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for ... providing engineering support for building automation and controls systems in...for building automation and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Metrology Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for ... metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will...policies and regulatory guidelinesHelp improve metrics performance to drive team results in areas of EHS, quality, compliance, cost,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …lead for equipment optimizations as well as system upgrades with the systems engineering team . This role will require technical expertise and troubleshooting ... will be an integral part of the CAR-T Equipment team in support of on-going clinical and...the various devices and ensure that the correct SLA ( Service License Agreement) is concluded.RequirementsBachelor's Degree - Preferably in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is seeking Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for providing ... operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner with Plant… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... a difference? The Position This role sits in the Clinical Data Sciences and Evidence (CDSE) Division. It plays...role works alongside with other colleagues in the Modeling team and HEOR teams to lead and execute HEOR… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …seeking an Senior CQV Specialist as part of the Commissioning and Qualification team based in Raritan, NJ. Role OverviewThis position will be responsible for ... providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be… more
- Merck & Co. (Lower Gwynedd, PA)
- …IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. ... will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the...leader to lead our Laboratory Operations and System Validation team . The successful candidate will coach and mentor staff,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking an Operations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Operations Manager is an exempt ... the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.Key ResponsibilitiesThis individual… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an Maintenance Specialist I (2nd and 3rd shift) as part of the Facilities & Engineering team based in Raritan, NJ. Role OverviewThis position will be responsible ... for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift. This individual will… more
