- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Vaccine Manufacturing Operations Technician - USA - North Carolina - Durham (Old Oxford) The Vaccine Manufacturing Facility ... Representatives Please Read Carefully-Merck & Co., Inc., Rahway, NJ, USA , also known as Merck Sharp & Dohme LLC,...known as Merck Sharp & Dohme LLC, Rahway, NJ, USA , does not accept unsolicited assistance from search firms… more
- Merck & Co. (Durham, NC)
- …as "remote".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. (Raritan, NJ)
- …will be providing technical content/strategics plans as part of collaborative working groups with cross functional partners (ie and competitiveness) to develop ... Company Information Legend 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)
- …include, but not limited to, managing activities leading to the successful execution of the risk assessment; establishing Risk Assessment plans with milestones and ... deliverables in collaboration with stakeholders (Quality, production, engineering, QC and process improvement and R&D etc.); conducting risk assessments; and ensuring accountability of team members for deliverables. Additionally, the Risk Assessment lead will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support area Manager and work closely with investigators to ensure investigations are completed on time and as per guidelines. Assign investigations to team members ... and track them to completion. Follow up with investigator on status of investigations, Corrections, CPAs and Effectiveness checks. Perform investigations and train new investigators. Collaborate with team to determine if corrective actions adequately addressed… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …Develop cell therapy gene editing platform and optimize cell-based immunoassays, including vector design, virus packaging, immune cell isolation and expansion, ... multi-color flow cytometry, ELISA, cytotoxic assays. In vivo study design and assay development. Design experiments to optimize process parameters, enhance cell engineering and manufacturing capacity. Independently design and execute experiments, document and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing quality oversight for the manufacturing process, equipment, and associated deviations and investigations within a cell therapy manufacturing plant to ... support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Leads, coaches and delivers a holistic, effective training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation, Technical Support, ... Supply Chain) that supports daily clinical production and strategically prepares for commercial supply of a CAR-T product. Manages, plans, coordinates, prepares and performs hands-on training curriculum in areas of general use, foundational and core skills,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Lead and supervise multiple units within the CAR-T process operations (ie component preparation manufacturing, MFG support operations, Mock cell, and CAR-T process) ... according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of shift operations meetings, the daily wrap up production meetings and assign individuals… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation investigations management system. Ensure alignment ... with GMP regulations and organizational objectives in all investigation activities. Standardize and improve the quality of investigations across the organization. Provide Technical Oversight: Offer technical expertise and guidance to investigation teams in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP ... Company Information Legend 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 leading a team of microbiology data reviewers supporting the reviewing microbiology data and documentation generated from the Environmental Monitoring program, ... drug product and intermediates testing from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment. The lead QC Microbiology Data Reviewer will also be responsible for the… 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. ... This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and complaint product supply. Key Responsibilities Support compliance activities for site… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Leads, directs, coaches and develops a holistic, effective training program for all plant functions and personnel that support daily clinical production and ... Company Information Legend 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)
- …Supervises an effective maintenance team that supports daily production of a CAR-T manufacturing facility. Maintains safety standards and training in the department; ... Company Information Legend 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)
- …Prepares and reviews documentation independently. Prepares and reviews documentation independently. Responsible for QC sample and retain management. Knowledge and ... Company Information Legend 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. (Piscataway, NJ)
- …Build and lead a talented team to develop novel technology and platforms for autologous and allogeneic cell therapy. Stay on top of the latest technology and ... development in the cell therapy field and act as SME. Develop and implement research plan with high scientific and technical rigor, provide good assessment and/or solutions to key issues. Effectively collaborate with research team in US, China, and Ireland and… 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 Information Legend 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 leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and ... Company Information Legend 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)
- …Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current ... Company Information Legend 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
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