- Merck & Co. (North Wales, PA)
- …/Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics ... Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and Assoc… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development. ... the internal engineering core teamsRemain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production with… more
- Merck & Co. (Rahway, NJ)
- …and future state business objectives. Within the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all areas of SAP ... SAP Middleware/Integration and Reporting/Analytics standards, patterns, and technologies.- They will lead the Technology Integration Meeting and provide Senior … more
- Merck & Co. (Rahway, NJ)
- …for commercializing new products.Technical Expertise:Utilize extensive experience in design controls , device transfer, control strategies device risk management, ... Job DescriptionJob Summary: -The Director of Device Technology Transfer is a key leadership role within...syringes, and complex drug delivery systems.Proven expertise in design controls , risk analysis, control strategies, design verification… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to experiment with us? The Position The Brand (Sema AD) HCP Experience Lead will play a critical role in ensuring helping ensure the successful execution of ... omnichannel execution. Relationships Reports to the Brand (Sema) Alzheimer's Disease Lead . Responsible for providing interface with key internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... SummaryThe Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to experiment with us? The Position The Content Management & Production Lead is responsible for developing and managing best-in-class capabilities and infrastructure ... programs. This role drives the adoption of content supply chain technology across Commercial Strategy and Marketing, and other organizational functions, leading… more
- Merck & Co. (Durham, NC)
- …peers in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. ... - The Lead Maintenance Technician is responsible for providing equipment troubleshooting,...documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaintsReview and approve manufacturing proceduresSupport regulatory ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the Quality team based in Raritan, NJ. Role OverviewThe Quality Compliance- Lead Auditor CAR-T is responsible for regulatory compliance supporting the ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- Insmed Incorporated (San Diego, CA)
- …with management to plan and execute the MSAT department strategy for technology transfer from process development through to commercial manufacturing. Facility fit ... Insmed Gene Therapy as subject matter expert during external and internal regulatory submissions and compliance inspections. Travel will be required to support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the...review process in a timely manner as necessary.- Change Control System: Manages an effective Change Control … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …artifacts o Security and protection of organizational data assets o Access Control leveraging administrative controls of data access rights for cross-functional ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in… more
- Tris Pharma (Monmouth Junction, NJ)
- …spanning neuroscience and other therapeutic categories employing our proprietary science and technology . Our science and technology make us unique, but it ... Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating… more
- Merck & Co. (Durham, NC)
- …related to graded area and aseptic processingServe as SME during regulatory inspectionReview and approve Operation, Technology , or Automation ... for leading a team that supports deviation management, change control , site qualification/validation, equipment qualification, and technical support quality for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and ... deployed and maintained following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems… more
- Merck & Co. (Durham, NC)
- …coordination leadership and implementation of troubleshooting activities and change control .Initiate and lead collaboration within the Operations, Quality ... of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This… more
- Aequor (Framingham, MA)
- …proposed platform and its impact in our early and late-stage biologics pipeline. Lead efforts for industrialization and technology transfer of proposed automated ... Relevant knowledge, coursework and/or hands-on experience in Process Analytical Technology (PAT), its applications (process monitoring, control , and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and ... optimize business processes, create data migration/conversion activities, and ensure adherence to regulatory requirements, including SoX, and CFR Part 21 and GxP as… more
- Eisai, Inc (Nutley, NJ)
- …system changes in a controlled environment to comply internal policies and /or Regulatory Controls (eg, SOX- Sarbanes-Oxley) #LI-TS1 Eisai is an equal ... want to hear from you. Essential Functions HCM Platform / System Technology Expertise Assists in defining future state solution architecture by establishing strong… more
