- Catalent (St. Petersburg, FL)
- …it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines).Provide QA Technical support during the development and manufacturing improvements throughout ... the design phase, technical transfers and routine productionProvide support to...technical concerns to determine trends affecting future designs, production activities.All Other Duties As AssignedThe CandidateBachelors Degree in… 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 ... direction, coaching, and technical expertise to operations personnel responsible for the manufacturing...individual must actively manage their assigned team to reliably support customer demand (including hiring as needed, employee development,… more
- Novo Nordisk Inc. (Durham, NC)
- …NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. OFP ... Novo Nordisk and help us make what matters. The Position Lead the technical analysis, process development/improvements & quality topics. Work with other members of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... CROs and External Vendors for the data services they provide to support drug development processes and global submissions.This position provides expertise within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …skilled technical experts to design, develop and implement Adobe Experience Manager (AEM) solutions that support digital transformation efforts and meet the ... components that perform well and operate smoothly and can handle unexpected technical problems effectively. If there are critical production issues, the… more
- Tris Pharma (Monmouth Junction, NJ)
- …other, and we believe in respectful, open and honest communications to help support individual and team success. Located in Monmouth Junction, New Jersey, Tris has ... an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager ,...company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally ... establishment and maintenance of validated systems. Coordinate technology transfer activities in support of commercialization. Serve as a technical resource to… more
- Novo Nordisk Inc. (Boulder, CO)
- …and drive plan execution. Proactively track critical path activities, anticipate risks, support creating contingency plans to ensure uninterrupted production and ... About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This individual will partner with Operations management and various site functions in support of personalized cell therapy production through safe and compliant ... Experience in several operational functions, eg Manufacturing, Quality, Supply Chain, Technical Operations Toyota Production System training and application.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and ... and manage change controls. Work closely with Operations Manager to help oversee the development of production...the first point of contact for operators on the production floor. Support the development of manufacturing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with CMOs as a primary contact thorough proper communication /alignment. Support Daiichi Sankyo Supply chain in managing CMOs. This includes coordinating ... continuous improvement. Coordinate efforts with CMO partners throughout actively monitoring production schedules. Collaborate with other DSI SCTO teams and cross… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …upstream and downstream changes, enable effective testing/release/code management, and provide post- production support using Agile methodologies. In case of ... supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining our facilities and assuring the integrity and… more
- Merck & Co. (Durham, NC)
- …globe.Our Company will construct a new manufacturing facility to significantly expand its production capacity for a medicine for the treatment of certain forms of ... we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …network and other manufacturing systems. This position provides Tier 2 and 3 support , technical recommendations and direction, and coordinate technical ... as our next generation of cutting-edge medications. It's not your average production site - it's a tight-knit, supportive community working together to contribute… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and maintain the system documentation Support the VRS solution and manage technical configuration and production issues. Support DSCSA related projects ... partners on technical readiness to meet DSCSA requirements and provide technical support for ongoing compliance activities Monitor and provide technical… more
- Novo Nordisk Inc. (Durham, NC)
- …NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. OFP ... the right quality, cost & timely completion of all deliverables. Relationships Manager . Essential Functions Ensure accuracy & compliance of validation & equipment… more
- Catalent (Manassas, VA)
- …Quality Plan (FQP) standards.Shift: 2nd Monday-Friday 1PM-9PM. Provide coverage during production runs on extended shifts and weekends, as needed. Location: ... Manassas, VA - this is a site based positionThe Role: Support the creation and maintenance of all documentation related to the Quality System utilizing technical … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate ... testing SOPs and specifications.Participate in proactive functions that impact production , increase efficiency, create cost savings, improve quality, and provide… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …technicians on processes and QMS systems. Essential Functions Liaison between Production Support and Manufacturing for the coordination of process/equipment ... multi-disciplined projects, with minimal supervision Understanding/application of quality systems Support of Health Authority inspections Possesses technical and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …as our next generation of cutting-edge medications. It's not your average production site - it's a tight-knit, supportive community working together to contribute ... assistance is available for this role. Relationships Reports to: QC Manager Number of subordinates with direct/indirect referral: 5-10 Essential Functions Oversee… more
