- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Manager of Operations - Continuous Improvement and Projects as part of the ... a continuous improvement culture. Requirements BS/BA required in technical discipline: Engineering , science, or similar field. Lean Six Sigma Green or Black belt… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Manager of Automation Engineering leads Automation Engineers and contractors responsible for instrumentation and controls of manufacturing ... (DQ) Validation Summary Reports, and Deviations reports for Manufacturing and process Equipment & Utilities.Co-ordinate and execute continuous improvement for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …established RD data governance frameworkPartner with RD Excellence to support ongoing process improvement related to data governance to ensure data integrity, ... rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global...a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting,… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The individual in this role must provide ... systems and knowledgeable of site procedures in order to resolve process /equipment issues, minimize downtime, and ensure product quality.This role will support… more
- Catalent (St. Petersburg, FL)
- …all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems; b) process improvement projects and Product Development Projects; c) all ... QA Product Manager Position SummaryThe QA Product Manager is...product process validation and cleaning validation documents; d) all Preventive Maintenance… more
- Catalent (Manassas, VA)
- …help create engaging new products consumers will love.The Site Procurement Manager is responsible for procurement leadership, sourcing and procuring materials, ... services, and capital for the site. The Site Procurement Manager will lead site procurement team and initiate and foster relationships with site stakeholders,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements in a sterile GMP environment. This role will serve as the business process owner for the Corrective and Preventive Actions (CAPA) process , and is ... records. Implement and lead CAPA site governance program. Drive continuous improvement of quality systems processes. Implement processes to ensure compliance with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Engineer, Process is responsible for engineering activities related to the development, improvement and optimization of the process ... and functions to assure appropriate information flow and understanding of overall process improvement direction, assist in the training of personnel as… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …/Greenfield Site Experience is a plus Must understand the entire development process through engineering program and project management, conceptual design, ... various projects. The Project Engineer will work directly with the Engineering team, Operations, Maintenance, and Manger of Project Management. Job Responsibilities:… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Manager /Sr. Manager , External Manufacture as part of the Technical Development ... production plan at the CMO's. Leads the management review process with CMO's based on agreed KPI's. Drives and...CMO's based on agreed KPI's. Drives and steers continuous improvement at the CMO and ensure timely execution of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …operations, including manufacturing optimization improvements and related cross functional Engineering /CAPEX projects, will give a solid grounding for incumbent in ... assistance eligible for selected candidate. Relationships Reports to: Sr. Manager Operational Excellence. Number of subordinates with direct/indirect referral: 6… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … Engineering and Manufacturing in the development of critical process parameters and provide technical leadership for deviation investigations Analyze data ... years' experience in the biotech/pharmaceutical industry in validation, quality management, process controls, and continuous improvement in an FDA-regulated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , IT Project Portfolio Management (IT PPM) is expected to contribute to ... portfolio level support to the Enterprise Program Management Office (EPMO). This Manager will contribute to three key areas: Integrated IT Project Portfolio… more
- Novo Nordisk Inc. (Durham, NC)
- …the appropriate cLEAN® tools within the main areas of Systematic Problem Solving, process improvement , & project management Operate within compliance with a ... from an accredited university with a minimum of two (2) years engineering experience in process -based manufacturing, utility, &/or packaging systems required… more
- Novo Nordisk Inc. (Boulder, CO)
- …With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and ... meeting production goals, the Technical Team Lead actively supports continuous improvement initiatives and identifies wherever possible improvements that reduce risk… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …system. Recognize and act on potential compliance issues and opportunities for process changes/ improvement . Partner with all stakeholders to implement process ... and technical feasibility of proposed changes. Serve as project manager for the change process and provide...Batch record revisions. Requirements BS/BA required in technical discipline: Engineering , science or similar field. A minimum of six… more
- Merck & Co. (Ames, IA)
- …critically analyze and solve problems.Planning and scheduling of pre-license serials, engineering batches, and field safety trial batches in production in ... logistics teams.Report on P&L and TTI metric tracking and support the Plant Manager & Finance with budget reviews.Ensure and promote compliance to company and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …include strategy enablement leveraging multiple skill sets such as project management, process improvement , change management and analytics. In addition, this ... with the approach, addressing cross-functional business impacts, dependencies and interdependencies. Process Improvement :Ability to identify and lead process… more
- Catalent (St. Petersburg, FL)
- …for managing and documenting events / discrepancies associated with either product or process as well as managing / writing any investigations that may be a ... and Standard Operating Procedures through the periodic inspections and monitoring of process controls in all applicable areas of the manufacturing operation. The… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …at our biologics manufacturing facility. Assists in coordination and execution of process and equipment improvement programs, creates technical reports, reviews ... This role will support our QC teams under the direction of the QC Manager . Relationships Reports to: Quality Control Manager Number of subordinates with… more
