- Outlier AI (New York, NY)
- …responses. Attention to Detail : Commitment to accuracy and ability to assess technical aspects of model outputs. Nice to Haves: Experience in fields like ... philosophy, theology, etc. Prior writing or editorial experience (content strategist, technical writer, editor, etc.). Interest or background in AI, machine… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role ... closely with Legend and Janssen partners to complete supporting technical documentation with an eye for global alignment templatesWork collaboratively… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Principal Scientist - Device Technical and Engineering Lead (Associate Director Equivalent) Our company's Device Product & Process ... suppliers for selected device technology platforms.Oversee and serve as a technical integrator of all device development activities including engineering design,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QC Technical Trainer III as part of the Quality team based in Raritan, NJ.Role ... OverviewThe QC Technical Trainer is an exempt level position working within...to day Quality Control Microbiology activities as needed.Perform peer review / approval of laboratory data as needed.Helps write or… more
- Aequor (Basking Ridge, NJ)
- …and GPMs. Design packaging requirements; based on a general understanding of the technical aspects of packaging in order to evaluate patient kit design and potential ... DS in collaboration with Outsourcing Vendor Management - Proactively review with the Vendor the study status on a...the Vendor the study status on a regular basis. Review the initial supply needs for start-up, ongoing resupply… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a Sr. Investigator as part of the Technical Operations team based in Raritan, NJ.Role OverviewThe CAR-T Sr. Investigator will ... be part of the Technical Operation team and will be responsible to provide specialist knowledge and expertise of cell and gene therapy processes and/or process… more
- Genscript USA Inc. (Piscataway, NJ)
- …technical lead for major capital projects, from design through commissioning. Review and validate design documents, technical specifications, and contractor ... Job Scope: The Facility Engineer serves as the primary technical subject matter expert (SME) for mechanical, electrical, and plumbing (MEP) systems—particularly… more
- Merck & Co. (Rahway, NJ)
- …Technology will be responsible and accountable for subject matter expert technical support for distribution and logistics of human health Drug Substance, ... Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and… more
- Merck & Co. (Rahway, NJ)
- …continuous improvement in biophysical characterization techniques and methodologies.Prepare and review technical reports, presentations, and documentation for ... and manage the biophysical characterization team, providing scientific and technical guidance, mentorship, and support.Develop and implement strategic plans for… more
- Formation Bio (New York, NY)
- …deliverables and compliance with GMP and regulatory standards. Documentation: Author and review technical documents in collaboration with Quality colleagues to ... on the Formation Bio pipeline. This role requires a blend of technical expertise, strategic thinking, leadership capabilities, and a strong regulatory and industry… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices ... (GDP). Review , revise, or draft Standard Operating Procedures (SOPs)Support processes that include aseptic process simulations, Commercial & clinical manufacturing,… more
- Merck & Co. (Rahway, NJ)
- …You will work with other engineers, product managers and technical leads,-you will help-to design systems, determine functional and ... for the enterprise-wide implementation of Databricks platform . Author, review , and maintain Terraform modules and state management for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a sterile GMP environment. This role will also provide oversight of technical , qualification, and validation activities including data or document review and ... for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer… more
- Eisai, Inc (Nutley, NJ)
- …execute on approved medical platforms/strategies and MSL initiatives Serve as technical /scientific subject matter resource to Eisai cross functional partners Teach, ... team members without a direct reporting relationship Research Support Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Compliance initiatives, such as inspection readiness, metrics implementation and review , overall regulatory compliance and implementation programs, and others as ... will also manage a team of people leaders and technical professionals within the QA department based on assigned...and gathering of quality metrics for Legend's Quality Management Review (QMR).Support management of the Quality Management Review… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …through completion.Schedule and participate in the site change control review board meetings.Manage change control metrics reporting.Collaborate with functional ... manner consistent with the safety policies, quality systems and cGMP requirements. Review change controls, SOPs, and other documentation.Require minimal direction to… more
- Merck & Co. (Rahway, NJ)
- …and resolve project obstacles and effectively communicate complex product technical challenges, design verification strategy, timelines, milestones, and risks within ... our Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking CQV Specialist II as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be ... departments or outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any… more
- Eisai, Inc (Nutley, NJ)
- …use of funds, and economic trends. Additionally, this individual will review cash requirements, plans and prepare short-term investments/borrowings to optimize daily ... between Treasury and IT, ensuring seamless integration and coordination of technical activities related to banking operations, system upgrades, and cybersecurity… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …resolution for manufacturing issues.Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints. ... setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.RequirementsA minimum of… more
