- AUROBINDO (Durham, NC)
- …internal standard operating procedures, and cGMPs. Previous GMP laboratory experience and technical reviewer experience are required. Review experience ... based on Total Prescriptions Dispensed. (We are#27 in 2010)Job OverviewCapable of performing technical review of laboratory experimentation against test methods,… more
- Takeda Pharmaceutical (Boston, MA)
- …sub-working groups and represents GRTs at project team meetings.Collaborate across technical functions to create innovative regulatory strategies for projects and ... and management; understands relative strengths, weakness, and probabilities of technical success for the mitigation strategies proposed.The Sr Director/Director will… more
- Takeda Pharmaceutical (Boston, MA)
- …identified risks and discussing with team and management; understands probabilities of technical success for the solutions.Accountable for all US FDA submissions and ... or leads departmental and cross-functional task-forces and initiatives.Lead regulatory reviewer in due diligence for licensing opportunities.Partner with global… more
- Takeda Pharmaceutical (Boston, MA)
- …identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions ... in departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global… more
- Raytheon (Burbank, CA)
- …the design and verification teams. You will be responsible for creation, review , and submittal for approval of all Radar Performance, Functional, Hardware, ... radar capabilities driven by new hardware and algorithm developmentProvide technical oversight for the execution of Radar Systems Requirement DevelopmentCollaborate… more
- Raytheon (Andover, MA)
- …in III-V semiconductor processing, preferably in GaAs, GaN or GaSb. They will review and oversee project schedules and cost, determine team priorities, review ... functional teams. Presence on the foundry floor is essential for understanding technical and logistical issues. The role requires a large degree of multitasking… more
- Raytheon (Marlborough, MA)
- …Development Engineer to support our Radar Product Line Team. We strive for technical excellence by drawing upon a workforce whose knowledge base covers the complete ... code, test, integrate, and document software solutions.Participate in internal review of software components and systems.Collaborate with project managers and… more
- CHRISTUS Health (Texarkana, TX)
- …fluid removal calculations, lung sounds and presence of edema, vital signs and review of current labs, assessment and care of the dialysis access.Obtains pre- and ... policy and procedure in response to dialysis-related complications, emergencies, and technical issues.Follows hospital and departmental policy and procedure in the… more
- Insmed Incorporated (NJ)
- …Collaborate with internal teams, CROs, and external vendors to prepare, review , and finalize clinical protocol documents.Contribute to scientific and operational ... study design planning through final reporting of result.Provide scientific input and review of protocol data, support in assessing medical monitoring reports, study… more
- Eisai, Inc (Exton, PA)
- …testing in the lab and will be expected to be a resource for resolving technical issues at CMOs and CROs. The individual will have demonstrated expertise in such ... meet project timelines. The ability to function in a fast-paced, highly technical environment, and ability to communicate effectively are essential. Job Summary The… more
- Merck & Co. (North Wales, PA)
- …main focus will be on document production processes, including content authoring, review and finalization, and feed to the Submissions Assembly team. The Business ... on requirements and design topicsSupport functional areas in identification and review of process questions and issues related to submission content management,… 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Compliance Auditor ... (Sr. Investigator) will be a key member of the Technical Operations team, responsible for ensuring adherence to regulatory requirements and internal quality… more
- Merck & Co. (Rahway, NJ)
- …individual to work in a fast-paced job that provides a high degree of technical , project, and people management responsibility. - This SSO Facility Lead role within ... the SSO Pilot Plant leverages significant depth and breadth of scientific, technical , and operational experience to lead and support facility operations, process… more
- Merck & Co. (Rahway, NJ)
- …Support compliance audits, inspection activities, and investigation/CAPAs.-- Author and review technical documents. Complete assigned work within established ... various stakeholders, including Analytical Development, External Capabilities, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address … more
- Aequor (Davie, FL)
- …assignments. Coordinate manufacturing of batches if required and prepare technical reports. Performing continuous process and cleaning verification, statistical ... remediation approaches and implement Corrective and Preventive Actions (CAPAs). Provide Technical assessments/ product impact assessment summaries on time to avoid… more
- Merck & Co. (Rahway, NJ)
- …and organized manner following ALCOA principals and SOPs. - Author and review technical documents. Complete assigned work within established project timelines. ... including Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical… more
- AUROBINDO (Durham, NC)
- …procedures and quality standards. Qualifications - Skills & RequirementsExcellent technical writing skills, communication skills, organization skills.Must be able to ... cause analyses, and identifying corrective actions.Experience in CAPA resolution and review of change Controls, SOPs, protocols/reports and quality indicator … 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
