- Merck & Co. (Rahway, NJ)
- Job Description Job Description: - The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & ... - Position Description/Summary: - The GPAM Associate Director, Project Manager , is a core member of Early Drug...in project management or a related role required - Product development experience required ; in a pharmaceutical/biotech industry… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …policies, procedures, and all applicable regulations.Key Responsibilities Manage the team responsible for drug product batch record review and drug ... multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in...oral, or diagram.Ability to deal with complexity across the drug product , the associated manufacturing process, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …develop, review and revise labeling for FDA submission, create and modify Structured Product Labeling for FDA submission, complete electronic drug listing, track ... new labeling for accuracy and consistency with CCDS.Create/modify labeling in Structured Product Label (SPL) for FDA submissionComplete electronic drug listing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, ... project management office to enable robust production, testing and release of product to patients.Key Responsibilities Helps to develop and support implementation of… more
- Genmab (NJ)
- …authentic is essential to fulfilling our purpose.The RoleThe Oncology Account Manager builds and maintains strong professional relationships with key customers and ... in the care of cancer patients. The Oncology Account Manager is a clinical and business leader who represents...the values of Genmab by providing approved, disease and product information and resources to key decision-makers and stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and hormone therapy products. Relationships The position reports to a Senior Manager , an Associate Director, or a Director in Strategic Pricing and Contracting. ... processes, analytic models and presentations Develops trackers and performance metrics for new product launch teams On an ad hoc basis, develops reports that monitor… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production...systems team, ad hoc, for activities such as annual product review, site risk register, or internal quality agreements.Develops… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be responsible for leading the development and ... Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), and their associated Patient Labeling Documents.Serve as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Operations Manager is an exempt level position working within Technical...within the facility to ensure high quality and compliant product supply and oversee production metrics. This individual will… more
- Merck & Co. (Rahway, NJ)
- …within and across teams and functions. Schachen Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation ... for Material Weight and Dispense, Solution Supply execution to meet Drug Substance Manufacturing Execution (Process Operations) requirements of New Product… more
- Aequor (Northborough, MA)
- …the Northborough Operations Center facility, is responsible for labeling and packaging of final drug product vials as finished product for sale and ... procedures and both written and verbal instructions from the supervisor/ Manager . Perform manual packaging on an assembly line. Ability...up to 35 lbs. and move heavy objects (eg, product vial cages, pallets of packaging materials). Ability to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for use. The Labeling Specialist is also responsible for maintaining product and establishment registrations ( drug /establishment listings) and submission to ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to… more
- Aequor (Bothell, WA)
- …inventory control and maintenance of samples and coordination of shipments of drug product and samples with external contract sites. Principal Responsibilities: ... Description: Repost 32704 (please do not submit candidates previously viewed by manager ) Position Summary: The Inventory Control Associate will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Drug Development Strategy: Provides input ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Merck & Co. (North Wales, PA)
- …role required Experience with the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle management ... management efforts to support Chemistry Manufacturing & Controls (CMC) product development from First in Human to Transfer to...- Position Description/Summary: - The CIPM Associate Director, Project Manager , is a core member of DCTs ,… more
- Genmab (Plainsboro, NJ)
- …for this location.Another focus of the role is the active support of product -oriented development (POD) teams in the security of processes related to (web) ... Genmab IT&Digital (IT&D) department is moving towards a value-driven and product -oriented department, the security leader will work closely with several POD… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides ... scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe QC Chemistry Finished Product Supervisor will report directly to quality upper management, (QC Senior Manager ), and will provide both ... corporate policies, and the regulatory requirements of the US Food and Drug Administration. The individual will be responsible for implementing policies and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …analyze critical process parameters (CPP) data, in-process testing data, and drug product release data to identify out-of-trend performance.Assist investigation ... validation (CPV).Provide timely and accurate update on the CMO performance to manager and cross functional stakeholders. RequirementsBS/MS is required, Ph. D is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …vein team (V2V) to plan, schedule and track the manufacture of autologous cell product batches at CMOMonitor the progress of product batches, identify and ... timely and accurate update on the CMO performance to the manager and cross functional stakeholders.RequirementsBS/MS is required, in related technical disciplines:… more
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