- Merck & Co. (North Wales, PA)
- …launch plans while leveraging agile strategies and methods.Serve as a launch excellence subject matter expert .Bring novel ideas to launch readiness across ... vaccines. As the Associate Director of Launch Strategy and Operations , you will play a vital role in preparing...or other applicable legally protected characteristics. - For more information about personal rights under the US Equal Opportunity… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …testing and release of product to patients in a cGXP environment.Key Responsibilities Acts as a subject matter expert ( SME ) for 21 CFR Parts 210, 211, ... Biotech is seeking Instrument Automation Engineer II as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Biostatistics and Data Management Data Operations team and serves both as a subject matter expert and leader of a group responsible for the business ... This position will also work with members of Data Operations , DM, and Biostatistics, Clinical Study teams, IT/ Information...the Clinical Data Repository. Functional Expertise: Serve as a subject matter expert and provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …EBR designs.Participate in design testing, release planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives ... but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations , QA, Reg CMC, and IT. This individual will support electronic batch… more
- Insmed Incorporated (San Diego, CA)
- …liaison with R&D on potency assay transfer into Analytical Development.Serve as a subject - matter - expert for cell-based potency assay cell line engineering, ... execution of program development from technical development, through manufacturing operations and culminating in the successful preparation of regulatory… more
- Merck & Co. (Rahway, NJ)
- …employees can thrive. Responsibilities include but are not limited to: Act as a subject matter expert in process development and characterization of ... ideal candidate for this position should be a recognized expert in the field, with demonstrated expertise in process...team members. Partner with functional area project teams and subject matter experts to establish and implement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …SPL drug Listing, FDA 2253s and Puerto Rico Registrations Labeling Tools: Serve as a subject matter expert in all labeling tools (SPL, TVT, Veeva Vault, ... Marketing and Supply Chain. Relationships Reports to labeling management in Regulatory Operations (RO), engaging with key company personnel within Novo Nordisk Inc.,… more
- Merck & Co. (Rahway, NJ)
- …final reports and publications summarizing data, and writing/updating lab SOPs.Serve as a subject matter expert in mass spectrometry-based assay development ... and validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical… more
- Merck & Co. (Rahway, NJ)
- …activities in support of clinical supply planning group (eg, process improvement initiatives, subject matter expert roles, cross functional projects, etc.) - ... partner s in both GCS (Logistics and Trade, Distribution, Operations etc.) as well as other organizations such as...proven ability to execute on collaborative projects and develop subject matter expertise - Knowledge of order… more
- Merck & Co. (Rahway, NJ)
- …of clinical supply chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise. - ... clinical supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make...or other applicable legally protected characteristics. - For more information about personal rights under the US Equal Opportunity… more
