- Merck & Co. (Rahway, NJ)
- …(INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead / support / oversee clinical supplies production with respect to device ... manufacture and final assembly of biologic/ drug product with device constituent part. Lead / support the development, implementation and continuous improvement of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Responsibilities- GLOBAL CHANNEL STRATEGY CREATION (LINKEDIN PRIORITY)- Lead the development and execution of a unified LinkedIn strategy that ... engagement.- Oversee social media agency supporting LinkedIn globalization efforts- Lead internal review process/submission for establishing global channel and… more
- Merck & Co. (Rahway, NJ)
- …Research & Development in our Company's Research Labs has an opening for a lead administrative assistant. Candidates must have an interest in and ability to work ... Some job responsibilities include, but are not limited to:-Administrative support to include extensive calendar management, meeting management (including meetings… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe ... Quality Systems Lead role is an exempt level position with responsibilities...systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the lives of more patients than ever before. The Position The Thought Leader Liaison Lead plays a pivotal role leading a team of Thought Leader Liaisons who will ... Customer Engagement and Integrated Solutions, Commercial Excellence, Legal, Regulatory Affairs, Compliance and other relevant NNI departments to ensure alignment of… more
- BioAgilytix (Durham, NC)
- …rather than days. Over time, the same foundation you build will support dashboards, predictive analytics, and other data-driven tools that boost lab productivity ... with hands-on responsibility for data quality, access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …risks/quality drift in external vendor and NNI processes to mitigate non- compliance and deviation occurrence Support internal and external stakeholders ... Health Authority inspections, including readiness activities, to ensure internal/external compliance with requirements/regulations Support , coordinate, and manage… more
- Merck & Co. (Rahway, NJ)
- …Improvements, Business Strategies, Business Technology, Change Controls, Computer Technical Support , Cost Management, Financial Management, GMP Compliance , ... and IT functions, and develop strategic digital roadmaps, and lead delivery of capital project digital programs.Responsibilities include:Planning and allocating… more
- Aequor (Devers, TX)
- …for the Procurement workstream, owning all related change management activities. Data Migration Support : Support and lead all discussions on data migration ... and ensuring data compliance from one ERP System to the other. Data...to Production data Loads. Cutover Planning and Post Go-Live Support : Lead / Support cutover planning from… more
- Merck & Co. (Durham, NC)
- …and external GMP and Financial audits, input to QSAT actions, to ensure compliance . Support the Master Data team with general Material Handling Steward tasksDrive ... warehouse operations and efficiency.- Additional responsibilities will include qualification support of off-site warehouse facilities for ambient and -70 storage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …escalates risks/quality drift in external vendor and NNI processes to mitigate non- compliance and deviation occurrence Support internal and external stakeholders ... strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Durham, NC)
- …& mitigation Lead the training & implementation of effective change management Lead Support Corporate, PS AM, local IT, & local stakeholder initiatives & ... areas of Systematic Problem Solving, process improvement, & project management Serve as the Lead and SME to operate within compliance with a quality mindset that… more
- Merck & Co. (Rahway, NJ)
- …Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support , Pharmaceutical Manufacturing, Regulatory Compliance , Root ... Job DescriptionAs a Technical Lead , you will report into Director, Chemical Technical...and intermediates. You will be responsible for providing process support , resolving production issues, evaluating process change requests, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and ... will be responsible for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile… more
- Merck & Co. (Rahway, NJ)
- …& tri-specific antibodies, and fusion proteins as well as the biopharmaceutic support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the ... large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and development of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... of the value chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to… more
- Merck & Co. (Rahway, NJ)
- …focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and ... with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project Management:Provide leadership… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily ... The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The… more
- Merck & Co. (Durham, NC)
- …to focus instrument performance and minimize downtime.Initiate and complete SOP revisions. Lead 8-step problem solving sessions to support investigations and ... leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a tangible impact on our… more
- Merck & Co. (Durham, NC)
- …downtime.Initiate and complete SOP revisions.Participate in 8-step problem solving sessions to support investigations and develop appropriate CAPAs which lead to ... capable of managing change in the pursuit of continuous improvement. Support projects with the potential to lead ...able to examine an issue from diverse perspectives (safety, compliance , automation, equipment, process, and people) in order to… more
