- Merck & Co. (Durham, NC)
- …Hiring Ordinance Search Firm Representatives Please Read Carefully-Merck & Co., Inc., Rahway, NJ, USA , also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA , ... does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …and Early Development team based in Philadelphia, PA. Role OverviewLegend Biotech USA , Inc. is seeking an experienced senior in vivo pharmacologist to join ... our in vivo pharmacology team responsible for conducting in vivo studies with mice and NHP to support pipeline development. This position will report directly to the Director of In vivo Pharmacology. The successful candidate should possess extensive knowledge… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This individual with provide direct support to the Director of Manufacturing Excellence by providing technical expertise to Technical Operations and ensure safe and ... compliant manufacturing operations according to cGMP requirements. This individual will support the hiring and development of Manufacturing Excellence associates. This individual will also own the process knowledge of the cell and gene therapy manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing quality oversight over the site Quality Control laboratories responsible for testing of pre-clinical, clinical, and commercial stage CAR-T cellular ... therapy products. This role will be responsible for reviewing and approving, of standard operating procedures (SOPs), validation/ qualification/ method transfer protocols, completed assay data and reports primarily for the quality control laboratories.Key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manage the team responsible for oversight of warehouse activities that include release of incoming Apheresis, Raw material, Spot check, pack out of final product ... material.Develop positive relationships with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers.Independently makes appropriate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing quality oversight over the compliance program for the site Quality Control laboratories in support of both clinical and commercial manufacturing. This ... role will be responsible for managing Laboratory Quality Investigation Leaders, approving critical site Laboratory nonconformance investigations, and tracking of quality metrics. This role will also be responsible for the management of the QA Lab Oversight… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …The Cleaning Validation Lead will establish and maintain the cleaning validation program / strategy for the site. The role is responsible for ensuring the program ... aligns across sites in the network and responsible for presenting the strategy in health authority inspections. Ensure site alignment with the manufacturing control strategy and microbial control strategy. Assess change controls and SOPs/Work Instructions for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Communicating accurate and up-to-date status reviews to appropriate personnel and updating status tracking spreadsheets and preparing reports Assist in the correction ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide technical expertise in the Technical Operations group, own the process knowledge of the cell and gene therapy manufacturing process technology to support ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support eBR development, modeling, and deployment in MESCoordinate with other departments to gather user requirements, guage effort, and deliver robust, right first ... time EBR designs.Participate in design testing, release planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Diagnoses, troubleshoot, repair, maintain, all types of HVAC, refrigeration, clean room HVAC, clean steam, cryogenic storage equipment and all types of process ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology… more
- Legend Biotech USA, Inc. (Iowa City, IA)
- …Drives multiple myeloma CAR-T brand choice amongst institution-based oncology customersComprehensive understanding of Legend and competitor products in our ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key ... Responsibilities Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP clean room environment.Ensure testing is completed in compliance with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for supporting the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP ... environment. This role will ensure compliance within the document management system, document storage and retention, and document issuance and reconciliation.Key Responsibilities Serve as a Document Control reviewer for new and revised procedures and documents… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for performing routine Environmental Monitoring sampling of the manufacturing facility utilized for cell therapy products for clinical trials and commercial ... operations in a controlled GMP environment.Key Responsibilities Responsible for performing routine EM sampling, including viable/non-viable air and surface sampling, related to the manufacturing of autologous CAR-T products for clinical trials and commercial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plantManages multiple and complex CQV ... projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required remediation efforts and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide technical expertise, train and manage an effective calibration program that supports daily clinical production and strategically prepares for commercial ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology… more
- Legend Biotech USA, Inc. (Boston, MA)
- …Identify KOLs within the assigned territory and establish and maintain scientific relationships with KOLs in both academic and community institutions.Execute ... activities at the assigned territory level in full alignment with Medical Affairs strategies and tactics.Assist in the oversight of Legend Biotech sponsored clinical trial sites to include, but not limited to, site identification, patient accrual discussions,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Leads and owns the Technical Training schedule weekly.Develops end-to-end training plans for new hires and supporting areas upon request.Assigns curricula to new ... hires according to learning journey.Maintains tracking and scheduling of yearly requalification's.Tracks progress of Operators and ensures on time completion of training.Track and maintains KPI's that impact site production capacity.Collaborates and stays… more
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