- Merck & Co. (Rahway, NJ)
- …ADCs, fusion proteins, combinations such as doublet or triplet co-formulationsSubject matter expert of process development and process characterization for ... Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such… more
- Aequor (Thousand Oaks, CA)
- …and Capital Equipment Global Category Management (GCM) teams Be the Procurement Process and Systems expert ensuring compliance with all relevant global ... Strategy and commercial price structure and incentives/penalties Facilitate supplier selection process , whether competitively bid or single sourced Draft and ensure… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Principal Scientist, Upstream Bio Process Development BPR&D within our Company's Research Laboratories is on a mission to ... Manufacturing while providing a diverse and inclusive environment for all. Beyond process development for pipeline biologics, we innovate and build next generation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on the creation and submission of RMPs and REMS. 2) Own and maintain the process for creating RMPs. 3) Provides expert , strategic advice on executing the ... requirements of RMP/REMS (including acquiring appropriate tools and competent vendors). 4) Guides and supports teams on tracking submissions (and following the status of submissions). 5) Guides in creating assessment reports. 6) Guides and supports with the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide front line support to ... position with responsibilities for providing quality oversight for the manufacturing process , equipment, and associated deviations and investigations within a cell… more
- Merck & Co. (North Wales, PA)
- …professional development, and performance management.May serve as a subject matter expert and/or participate on process improvement teams.Required experience and ... inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here...you need an accommodation during the application or hiring process . We are an Equal Opportunity Employer, committed to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and ... if applicable.Ensure Compliance with Labeling Regulations and Guidances: Demonstrate expert knowledge of global labeling guidances. Ensure compliance with internal… more
- Merck & Co. (Rahway, NJ)
- …update of local Standard Operating Procedures (SOPs) / Business Procedures (BPs) Expert for any quality-related processes.Identifies process gaps / opportunities ... operations to implement local/regional/global processes/procedures, to identify opportunities for process improvement, and to support continuous improvement initiatives. Advanced… more
- Merck & Co. (Rahway, NJ)
- …in interviews with our company's' stakeholders to capture user requirements and process flows, lead and participate in design, and build solutions with business ... Execution, Quality and Logistics. This role also provides close support to the Process Stewards, Product Owners and Business and IT partners with a focus on… more
- Merck & Co. (Rahway, NJ)
- …p articipate in interviews with our stakeholders to capture user requirements and process flows, lead and participate in design, and build solutions with business ... Production Execution, Quality and- EHS. This role also provides close support to the Process Stewards, Product Owners and Business and IT partners with a focus on… more
- Lundbeck (Bothell, WA)
- …Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global ... a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team.The Lu-SBP team leads and...and validations and ultimately serving in a Subject Matter Expert role. Key to the position is a thorough… more
- Merck & Co. (Durham, NC)
- …people.This position is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are ... limited to activities of: Media Preparation, Fermentation, Tangential Flow Filtration, Process Monitoring, Sampling, and area cleaning. As a Senior Technician you… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities. The Director serves as primary functional partner and MCT subject matter expert for the MCT integrated technology ecosystem and partners with the Digital ... plans for optimizing global MCT operations, processes and technology based on expert knowledge of opportunities and challenges within the function, company and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Senior Analyst will be the Master Data Management (MDM) primary Subject Matter Expert (SME) for Market Access and Public Affairs (MAPA), Pricing & Contracting ... Role will work with MDM system and become an expert in how to use the MDM tool to...employed by NNI field systems Manage HCP Specialty Matrix process , ensuring all procedures are followed and keep all… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and execution of the Global Manufacturing & Supply (GMS) data governance process , from material creation to consumption across Warehouse, Materials Planning, Work ... Master Data Management program. We are looking for a well-organized and process -oriented leader, with strong understanding of Manufacturing & Supply Chain Management… more
- Insmed Incorporated (Bridgewater, NJ)
- …strategies across all regions including Scientific Engagement Model, Medical Expert Engagement Planning, Coaching Framework, Field Impact Assessment, MSL functional ... their needs/challenges, align on strategy/solutions/initiatives/projects and co-create throughout the process , roll out initiatives, and provide support for assigned… more
- Merck & Co. (Boston, MA)
- …PDMB efforts as a project-team representative and PK/PD subject matter expert , regularly interacting with multi-disciplinary discovery teams and partners from other ... your primary roles will include:Project-team representative and subject matter expert on protein therapeutic-based PDMB activities including generation and… more
- Catalent (St. Petersburg, FL)
- …but not limited to Master Batch Records; Master Shipper Labels, Process recipes, various technical protocols (Pre-Commercial Clinical Packaging Protocols, Process ... Validation, Bulk Mfg Protocol and Reports (non-GMP, Clinical, Registration, Process Validation, Product Transfer, etc.), Risk Assessment, Formulation Reports,… more
- Merck & Co. (Rahway, NJ)
- …elements of drug development and effective communication skills. As a subject matter expert , the Associate Director within the Group will work closely with teams of ... on drug development teams. Primary Responsibilities: Serving as an expert representative for on Oncology clinical development teams.Framing critical questions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provide updates, ensure alignment and monitors vendor activities Should have an expert understanding of the software development lifecycle, while working with hybrid ... are required Excellent interpersonal, negotiation, written and oral communication skills Expert knowledge of systems analysis and design techniques Knowledge of all… more
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