- Merck & Co. (Durham, NC)
- …Software, Calibration of Equipment, Commercial Property Management, Commercial Real Estate Acquisitions, Computerized Maintenance Management Systems ... pharmaceutical manufacturer? If so, then this is the opportunity for you!Senior Maintenance Technician- is a member of the Engineering team providing technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Maintenance Technician Specialist as part of the Technical Operations 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… more
- Aequor (Pearl River, LA)
- …in the media, buffer and solution preparation areas of the cGMP commercial manufacturing facility. Requires good documentation skills and attention to detail. Duties ... will include the operation, maintenance , cleaning and sanitization of media and buffer equipment...The incumbent should be proficient in aseptic technique, preventive maintenance , and changeovers for area equipment, including biosafety cabinets,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with Training team ... facility approval of a state of the art cell therapy facility for commercial launch and sustained production. The role will require technical experience, effective… more
- Bayer (Myerstown, PA)
- …component specifications; qualifying components and packaging operations; troubleshooting commercial packaging operations; and implementation of quality and cost ... reports for new modified packaging equipment. Develop and oversee maintenance of packaging documentation: Monographs, Specification templates, Packaging Study… more
- Merck & Co. (Rahway, NJ)
- …Procurement team as an Associate Director to look after manufacturing equipment maintenance , repairs and operations services ("MRO services") globally. This is a ... sourcing events (RFQs, RFIs, RFPs), and support vendor selection, commercial negotiation and contracting.Support and implement Supplier Relationship Management with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …execution of regulatory guidelines across all manufacturing areas, supporting both clinical and commercial sites. This individual will be a key leader in the Global ... the development of the GMP Compliance program related to clinical/ commercial stage and manufacturing.Support Legend's regulatory program and monitor the regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible ... Operating Procedures (SOPs)Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and real-world evidence generation supported by disruptive innovation and trendsOversee maintenance and advancement of Global MA Tools and Technology through ... and systems supports the digital roadmapCoordinate with other internal digital functions ( Commercial , RD, Japan, IT, etc) across DSFunction as a strategic thought… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will work within an Operations ... trainees who support daily clinical production and strategically prepare for commercial supply of a CAR-T productManages, plans, coordinates, prepares and performs… more
- Insmed Incorporated (NJ)
- …and complete mitigation strategiesCollaborate on system design, UAT testing, maintenance , to ensure robust supply tracking and randomization supportCollaborate with ... CMC, Clinical Ops, Quality, Regulatory, and Commercial Supply teams to align clinical supply efforts with broader D&OP / S&OP and processes and commercial … more
- Merck & Co. (Rahway, NJ)
- …distribution centers, with whom our company interfaces.Document preparation, maintenance , and review of documentation including testing protocols, testing ... well as Risk Management tools.Understanding of new product introduction, commercial supply, lifecycle management.Proven project leadership and complex problem-solving… more
- AUROBINDO (Durham, NC)
- …Assists in scale up and transfer of processes from pilot to exhibit and commercial scaleMaintains a state of readiness of the MDI process equipment by performing ... preventive maintenance , calibration or functional modification as necessaryCharacterizes active pharmaceutical ingredients (APIs) for respiratory products using… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for Quality Control Microbiology team members who support cGMP Clinical and Commercial Cell Therapy testing. This role will require technical experience, effective ... environments.Serve as subject matter expert for Learning Management Systems.Support the maintenance and reporting of quality training metrics.Other duties will be… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving ... and determine resolution for manufacturing issues.Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and… more
- Daiichi Sankyo, Inc. (Chicago, IL)
- …business trends; develop and execute business plans that optimize the commercial potential of our products. Inform strategic business decisions through collaboration ... expectations and standards, including budgets, reporting, and communication. Oversees maintenance of key customer target list.Effectively manages District's budgetModels… more
- Merck & Co. (Rahway, NJ)
- …produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We ... teams.Support establishment of GxP systems in the facility: Change Management, Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operational excellence continuous improvement support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead continuous ... or efficiency gains in multiple functions (Production, Engineering, Facilities, Maintenance , QA, QC, etc.).Proven knowledge and demonstrated experience of designing,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide ... utilities, and facilities qualification, shipping validation, data integrity, and maintenance activities within the siteReview and approve qualification/validation documentation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in ... Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plantManages multiple and complex CQV… more
