- Merck & Co. (Durham, NC)
- …technical /team support for commercial analytical assays (UPLC, Solo VPE) Author technical documentation associated with the development and implementation of ... timelines. Lead aspects of regulatory inspections by presenting and defending technical documentation , investigations, and change controls Provide post approval… more
- Merck & Co. (Rahway, NJ)
- …process commercialization.Experience in leadership of CMC development teams.Experience authoring technical documentation in support of the following: process ... the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline… more
- Merck & Co. (North Wales, PA)
- …Current Good Manufacturing Practice (cGMP) awareness or experience Authoring of technical documentation in support of the following: process performance ... the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the employees in the maintenance process, the information from SAP, the technical documentation and other data systems. With this information, the Asset ... myeloma.Legend Biotech is seeking an Asset Reliability Engineer as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Asset / Reliability… more
- Aequor (Chattanooga, TN)
- …drawing development. o Ability to read and understand engineering drawings and technical documentation o Excellent written and oral communication skills; able ... is responsible for providing project management, design engineering, and ad-hoc technical support of packaging and processing operations. They are responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to act as an advisor to North America ... of new and existing CMR employee on-boarding, cultural engagement, technical /role-specific training and GxP/Regulatory compliance across CMR functions. Position will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and supports oversight and ... of integrations solution design, implementation strategy and requirements gathering, and technical feasibility and delivery. The role supports all phases of systems… more
- Merck & Co. (Rahway, NJ)
- …development to ensure completion of key milestones and laboratory / regulatory documentation . Active strategic and technical leadership on program development ... Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task,… more
- Merck & Co. (Durham, NC)
- …samples based on internal metrics and production needs.Author/review technical documents, method transfer/qualification reports, standard operating procedures, ... investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative ActionsExecute test method… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides a high degree of technical and project management responsibility.-This SSO Process Engineer role within the SSO Pilot ... Plant leverages scientific, technical , and operational experience to support facility operations, process development activities, compliance investigations/change… more
- Merck & Co. (Rahway, NJ)
- …individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. - This SSO Process Engineer role within the ... SSO Pilot Plant leverages significant depth and breadth of scientific, technical , and operational experience to support facility operations, process development… more
- Twist BioScience (South San Francisco, CA)
- …diagrams), prioritization matrices, business requirements documents, and technical requirements documents.Perform structured analyses of business requirements ... of modeling techniques.Create a shared understanding among business and technical teams and uncover non-obvious needs.Incorporate quality into product design,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …on a modified second shift. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe ... for commercial launch and sustained production. The role will require technical expertise and troubleshooting ability to drive effective and robust production,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a strong working knowledge of medical terminology concepts and industry standards and technical skills in coding data received from CROs and vendors. This position ... (MedDRA and WHO Drug Coding dictionaries) including dictionary support documentation . Collaborates cross-functionally with the Medical, Clinical Development, Clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and without errors. This role requires strong organizational skills, problem-solving skills, technical knowledge, and the ability to work in a fast-paced GMP ... Monitor test execution, adjust schedule as needed to address tests failures. Documentation : Maintain detailed documentation of tests schedules, procedures, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking Instrument Automation Engineer II as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be ... tasks.Acts as an SME for internal and external agency inspections.Supports technical and quality investigations, CAPAs and corrections.Develops and performs any… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the creation, management and execution of engineering life cycle documentation and verification (ie commissioning through qualification) for manufacturing systems ... science and risk-based verification requirements and is required to supply support/ technical knowledge for the development/refinement and implementation of the GEP… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides a high degree of technical leadership and mentoring.- This position leverages significant depth and breadth of scientific ... and technical experience to lead small molecule drug substance process...and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).-A high level of innovation, creativity, and… more
- Merck & Co. (Durham, NC)
- …activities and routine product testing to include the following:Author/review technical documents, standard operating procedures, change controls, and investigations ... audits and inspections (regulatory, internal, safety)Assist regulatory groups by providing documentation to support the approval of licensure supplements and new… more
- Merck & Co. (Rahway, NJ)
- …limited to the following:Consult on any proposed utilization of platformManage technical aspects of standups which includes estimation and supporting refinement of ... storiesExecute on defined release strategy for the platformResponsible for documentation of all procedures to support the development, deployment and use of the… more
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