- Insmed Incorporated (NJ)
- …trail reviews.What You'll Do: Develop risk-based validation strategies for system implementation and changes following CSV SOPs and Work Instructions Coordinate all ... systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical /Manufacturing systems.Minimum of a Bachelor's Degree in Computer Sciences, Engineering,… more
- Aequor (Thousand Oaks, CA)
- …automation (eg, liquid handlers, tube handlers, etc.); develop vendor assessments and implementation plans. Author, revise and own SOPs and protocols to enable ... process improvement and laboratory automation projects from pilot through implementation /transfer. Proficiency with digital lab documentation and data tools (ELN,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing operational excellence continuous improvement support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead ... supervision prior to submission.With respect to larger continuous improvement system implementation and improvements, you have the authority to engage with functions… more
- Eisai, Inc (Exton, PA)
- …and lead investigations into assay failures, OOS/OOT events; direct the implementation of CAPAs and evaluate their effectiveness. This position primarily oversees ... and lead investigations into assay failures, OOS/OOT events; direct the implementation of CAPAs and evaluate their effectiveness. This position primarily oversees… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Business Support: Develop solutions to effectively address issues/obstacles and ensure implementation and communication of best practices Enhance the PSP customer… more
- Eisai, Inc (Nutley, NJ)
- …Medical Information Manager is responsible for contributing to the development and implementation of the Medical Information component of the strategic plan for ... manufacturers' communications and dissemination of medical information. Knowledge of clinical trials, drug approval processes, and clinical application… more
- Taiho Oncology (Seattle, WA)
- …and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources ... use. The OAM will drive sales through their face-to-face interactions and implementation of innovative tools and analytical processes, while working closely with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ... cGMP manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.GxP Quality System knowledge, including… more
- BioAgilytix (San Diego, CA)
- …Manager II will lead scientific and operational activities in support of preclinical, clinical , and product release studies for our San Diego lab. This role requires ... team(s) developing and validating bioanalytical assays for support of preclinical, clinical and product release studies.Motivating team by inspiring employees to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the past 2-3 years) focused on biomarker discovery, subgroup and clinical efficacy prediction.Categorize methods by approach (eg, deep learning, ensemble learning, ... survival analysis, multi-omics integration) and application area. 2. Prototype Implementation and BenchmarkingImplement selected methods using internal or publicly… more
