- Merck & Co. (Rahway, NJ)
- …validating platform and innovative device/CP functional test methods with high technical rigor to support development, IND-enabling stability, commercial ... validating platform and innovative device/CP functional test methods with high technical rigor to support development, IND-enabling stability, commercial… more
- Novo Nordisk Inc. (Boulder, CO)
- About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as ... Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, … more
- Genmab (Plainsboro, NJ)
- …operating model for this location.Another focus of the role is the active support of product -oriented development (POD) teams in the security of processes ... of the underlying operational and commercial business processes. The support of our office in Japan requires a very...that security requirements and definition and implementation of security controls are an integral part of the product… more
- Aequor (Swiftwater, MN)
- …activities at Swiftwater. The incumbent manages regulatory activities linked to change controls for the site, including the update of CMC files. The incumbent ... is accountable for product license maintenance and site registrations. The incumbent also...CMC regulatory documents (modules 1.2, 2.3 and 3) to support Marketing Authorizations and other documentation that support… more
- Merck & Co. (Durham, NC)
- …and routine product testing to include the following:Author/review technical documents, standard operating procedures, change controls , and investigations ... to support the approval of licensure supplements and new product license registrationsCollaborate with Durham Laboratory Compliance to ensure adherence to… more
- Tris Pharma (Monmouth Junction, NJ)
- …and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating Procedures (SOPs), ... directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership,… more
- Aequor (Thousand Oaks, CA)
- …Computer Engineering or equivalent experience Medical device and/or combination product development experience; design controls experience 4&plus years' ... DeviceResponsible for coordination, status reporting and stability of Combination Product Operations (CPO) project activities. Manages one or more cross-functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …collaborative team setting with Quality, Manufacturing Operations, Facilities & Engineering Quality Control , Operations Technical Support , Supply Chain and ... is seeking CQV Specialist I as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis...will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy… more
- Merck & Co. (Rahway, NJ)
- …and deviation investigations, ensure permanent inspections readiness, regulatory inspection support and monitoring, change control oversight and management, ... metric review, and review of annual product reviews. This also includes building effective quality systems...development of the CTLs Team budget and tracks and controls expenses as needed to meet budget. This includes… more
- Tris Pharma (Monmouth Junction, NJ)
- …each other, and we believe in respectful, open and honest communications to help support individual and team success. Our AR&D lab is located in our Monmouth ... (AR&D) teams in analytical method development, physical characterization, formulation support , interim validation, pilot release testing and stability testing… more
