- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... implementation, and integration of GxP-regulated systems across the organization. This position...requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the methodology,… more
- Repligen (Rancho Dominguez, CA)
- OverviewWe are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer ... as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation, and… more
- Merck & Co. (Rahway, NJ)
- …We are seeking a Product Analyst to be a change agent for our order-to-cash process . This role offers the opportunity to lead and execute key projects and ... with the business via managing specific Order to cash process area or subject eg Order management, Customer Master....our platforms and processes. Handle small projects as a lead analyst, project manager, or as the… more
- Novo Nordisk Inc. (Durham, NC)
- …tools within the main areas of Systematic Problem Solving, process improvement, & project management Serve as the Lead and SME to operate within compliance ... datasets from wide variety of data sources Support manufacturing, business, and project departments with process understanding, analyses, and systematic problem… more
- Merck & Co. (Rahway, NJ)
- …writing / review of regulatory filings including INDs and NDAs.Exposure to project / engineering work process and deliverables (eg equipment fabrication, ... products and understanding of parenteral formulation development.Knowledgeable of the Capital Process having participated on a large capital project … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and tactical guidance to all levels of internal stakeholders through the integration of primary market research and secondary data analytics. Incumbent must have ... and oversee the work of support staff that will assist in the project execution and management of specific research projects. May supervise junior market… more
- Merck & Co. (Rahway, NJ)
- …Overview: As the Associate Director of Launch Strategy and Operations, you will lead the enterprise preparation of multiple product launches in Immunology. You will ... leadership capabilities. Key Responsibilities include: Strategic LeadershipLaunch Strategy Development: Lead the creation of holistic, integrated launch plans that… more
- Twist BioScience (South San Francisco, CA)
- …integration (eg, ERP, LIMS, QMS) using APIs, web services, or other integration technologies.Excellent project management skills, with a track record of ... experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom,… more
- Formation Bio (New York, NY)
- …adapting style to different audiences and simplifying complex information. Lead productive team meetings, fostering collaboration and ensuring clear action ... in a matrixed environment. Partner with the Program Leader to support and/or co- lead the program Drive decision-making and ensure full participation from all team… more
- Merck & Co. (North Wales, PA)
- …pediatric vaccines in the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of development therefore requiring ... the functions and processes relevant to vaccine development, and project management principles as applicable to the pharmaceutical industry.Primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …projects.At the time of implementation of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data ... and Switzerland. CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory...risk determinations (both submission to CDRH in a Q-sub process and in a streamlined fashion within protocol submission… more
- Formation Bio (New York, NY)
- …efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities related to biologic ... with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC team; foster a culture of ownership, innovation, and… more
- Eisai, Inc (Nutley, NJ)
- …and successful execution of clinical studies in accordance with the overarching project plans established by the various International Project Team Leaders ... (IPTLs). This role requires a deep understanding of the entire clinical trial process , from initial planning and protocol development through to study close-out and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this position has advanced skills in continuous improvement, project management, change management, and risk managementResponsibilities: Leadership, Direction, ... of the global data management strategy across regions and across studies/programs. Lead DM resource model internalization for both strategy and implementation in… more
- Mindlance (Boston, MA)
- …(APIs) or database management. *Performed in a business analyst role for an integration project with external customers. EEO: "Mindlance is an Equal Opportunity ... utilization of technical services to resolve business problems; manage customer expectations; may lead re-engineering team and act as project manager to assist… more
- Antares (Los Angeles, CA)
- …Own and manage the Antares Research and Development (R&D) reactor assembly and integration processes Define the standard process and workflow for manufacturing ... and beyond, you will be responsible for leading the manufacturing planning process and will assist with in-house manufacturing vs. outsourcing trades and vendor… more
- iSpace, Inc. (Torrance, CA)
- Title: Enterprise-wide Modernization IT Project Manager Location: Torrance, CA (100% onsite role) Duration: 8 Months with possibility of an extension We are looking ... highly motivated, team-oriented, and customer-focused Senior Program Manager to lead a complex, enterprise-wide modernization program. The successful candidate will… more
- iRF Solutions (Sparks Glencoe, MD)
- …add or change the duties at any time. Job Description: Reporting to the Systems, Integration and Test Engineer Lead , the Systems, Integration and Test ... and units using best practices Creating test procedures to document entire testing process from bench integration to automated acceptance testing. Works with… more
- HORNE (Tampa, FL)
- …the completion of project tasks and monitor adherence to perpetual project management process standards. The Construction Manager must have knowledge and ... project plans for the efficient execution of project tasks. Develop clear, straightforward plans that lead...to empower people. An inclusive culture that promotes career/life integration and invests in developing people in areas of… more
- SpaceX (Hawthorne, CA)
- …into the design and development of new and existing hardware and take a lead role in manufacturing and integration on our current and next-generation vehicles. ... RESPONSIBILITIES: Responsible for the build and inspection process for the structural assembly and integration of the Falcon launch vehicle Develop, qualify, and… more
