- Verista (Woburn, MA)
- …new skills and learn from our experiences to enhance our collective expertise Validation Lead (Laboratory) Analyst Responsibilities: + Perform validation ... from vendor manuals + Perform method transfers + Independently lead the Client through the Validation Lifecycle...+ Independently lead the Client through the Validation Lifecycle required for their identified equipment Requirements +… more
- Verista (Norwood, MA)
- …+ Perform Study on path forward of SDMS within Moderna CMC Quality testing Labs : + Driver to implement SDMS + Compliance on e-record audit trail, versioning, access ... control, archival & retrieval + Homogeneous Data output format via integration/parsing/upload + Security + Market and active providers of SDMS + Traditional SDMS & vendors + Market Majority: NuGenesis + LogiLab + Integration and Storage + Scitara, Zontal,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …standards and procedures at Takeda. + Partner and align with SBOs, QSIs, DD&T OpU Lead , DD&T Leads, enterprise QC labs leadership and GMSGQ key stakeholders to ... includes product related microbiological and utility monitoring. + Foster QC labs , Sample logistic, Manufacturing area, Sterility Assurance and COA creation… more
- Amgen (Cambridge, MA)
- …and testing sites. + May lead method transfer to CMO or contract testing labs . + Review and approve protocols, reports from CMO and contract testing labs . + ... analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. + May lead and mentor a small group of scientists. **What we expect of you**… more
- Sanofi Group (Framingham, MA)
- …a continuous process platform. The function is responsible for tech transfer, process validation , dossier preparation, & PAI support to enable launch of new and LCM ... products. We are pursuing future innovations such as digital labs , factory of the future, and advanced-analytics-based process understanding and control. The… more
- Takeda Pharmaceuticals (Lexington, MA)
- …equipment and software. + Manage and provide equipment/inventory management services to all R&D labs . + Establish, lead and manage team of full-time and contract ... software/hardware upgrades for existing equipment. + Identify opportunities and lead initiatives to collaboratively improve service levels and business processes… more
- RTX Corporation (Tewksbury, MA)
- …technical objectives are met. Job duties include classified activities in secure labs and unclassified activities in a dedicated workspace. Common SWQE tasks involve ... training manuals, user guides, customer deliverables. + Systems Integration: labs , software, hardware, connectivity, tools, equipment. + Test Witnessing: test… more
- AbbVie (Waltham, MA)
- …programs in early and late stage oncology clinical development. + Lead and coordinate resources from multiple functional areas (Biomarker research, Regulatory, ... area leads. + Oversee implementation of clinical trial assays at reference labs and centralized testing vendors. Monitors all changes in study scope ensuring… more
- The MITRE Corporation (Bedford, MA)
- …will be of special interest. The CE will be expected to work across MITRE Labs to develop joint efforts with the other Innovation Centers to identify and win ... and economic growth. This is a unique opportunity to lead and shape the future of our organization and...strategies, as well as technology development, deployment, verification, and validation that drive work- product quality and impact. +… more
- Beth Israel Lahey Health (Wakefield, MA)
- …research, and enhanced patient outcomes **Job Description:** * Serve as the lead organizational resource on data availability and differences by source. Document ... for guiding the Data Integration Analysts with ongoing data collection and validation from multiple data sources. Develop processes and write queries to monitor… more