- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug ... its associated sub-teams. Accordingly, the candidate is responsible for executing the technology transfer in accordance with the established standard processes… more
- Merck & Co. (Rahway, NJ)
- …design, equipment selection, vendor interaction/management, factory acceptance testing, technology transfer support, construction support, equipment ... Senior Specialist operates under the guidance of the Technical Engineering and Technology Directors supporting Line of Business with focus on a growing portfolio… more
- Novo Nordisk Inc. (Boulder, CO)
- …during production to provide suitable root cause investigation analysis Support the technology transfer of manufacturing processes into Phase I/II cGMP ... lyophilizers, and analytical instrumentation In collaboration with Chemical Development, transfer and scale-up processes from laboratory to pilot plant scale… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing sites. Extensive knowledge in cell therapy operations, technology transfer , investigations, capacity/throughput studies, strategic capacity ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- Merck & Co. (Rahway, NJ)
- …design, equipment selection, vendor interaction, factory acceptance testing, technology transfer , construction support, equipment qualification, facility ... Director operates under the guidance of the Technical Engineering and Technology Directors supporting Line of Business (Biologics, large Molecule etc.) with… more
- Merck & Co. (Rahway, NJ)
- …/processes, training opportunities for improved manufacturing process development, and seamless technology transfer to commercial sites. The SSO Operations ... equipment with the aim of advancing process development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical… more
- Novo Nordisk Inc. (Boulder, CO)
- …Physical Requirements 0-5% occasional overnight travel (domestic or international) to support technology development and technology transfer to commercial ... manufacturing. Ability to lift 0 - 20lbs. Development of People Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …validation team in the establishment and maintenance of validated systems. Coordinate technology transfer activities in support of commercialization. Serve as a ... technical resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development and validation of new products, as… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …individual is responsible for managing and executing IT/OT (Information Technology /Operational Technology /Automation Engineering) projects of moderate complexity ... Quality Assurance and Quality Control, on project teams to facilitate design, transfer , and start-up of IT/OT projects Ensure compliance with the Quality Management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(SOPs/SOIs), including external data templates, such as External File Transfer Specifications (EFTs), External Data Structure Specifications (eDTS) to ensure ... Operations, Data Management, CROs and oversee the Diagnostic Partners data transfer activities with functional and cross functional area leads.Collaborates with… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... / orchestration tools (Tidal Enterprise Schedule or equivalent), enterprise Managed File Transfer tool (Cleo Harmony or equivalent). Must be able to independently… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents (SOPs/SOIs), including external data templates, such as External File Transfer Specifications (EFTs), Data Structure Specifications (eDTS) to ensure data ... with Study Data Managers to oversee quality of external data, transfer standards, and issue management. Ensure consistency of standard implementation across… more
- Aequor (Seattle, WA)
- …troubleshooting/root cause analysis when issues arise, during cross-site material transfer process. Identify, maintain, and manage master data needs/gaps to ... ensure a smooth cross-site material transfer process. Serve as a subject matter expert (SME)...record of leading large process improvement projects and complex technology projects. Comfortable working in fluid situations with competing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Summary: This is a leadership role within the Technology Design and Customer Interface Team. The chosen candidate will be responsible for ... adoption, deployment, marketing, and commercial activation for the new field of Swine Technology .The person in this role will work closely with our Tech labs 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 ... Role Overview This position will be responsible for managing the technical transfer and clinical/commercial manufacture of cell therapy products in our external… more
- Merck & Co. (Rahway, NJ)
- …development of continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific ... and/or pilot-scale studies to support mechanistic understanding, scale-up, and transfer of processes to manufacturing. Collaboration and effective communication:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across CMR functions within the role-based training processes (ie automation, technology , process optimization). Relationships Reports to Director or above within ... with the latest industry trends, regulations, and best practices Facilitating the transfer of critical knowledge and expertise from experienced personnel to new… more
- Merck & Co. (Rahway, NJ)
- …not only on drug development pipeline projects, but also innovative technology teams shaping analytical methods and tools of the-future.- Author investigational ... professional organizations, conferences, and publica tions as well as analytical technology and regulatory sciences related focus groups and consortia. -… 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 is ... and dissolution apparatus (Distek)Collaborates closely with R&D for analytical method transfer studies and other analytical method related issuesAssists with the… more
- Merck & Co. (Rahway, NJ)
- …Scientists use cutting-edge science to transform drug delivery and manufacturing technology to positively impact patients.The Oral Formulation Sciences (OFS) team is ... product compositions and processes, GMP manufacturing considerations and scale-up/tech transfer activitiesDemonstrated experience solving program challenges by leveraging a… more
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