- Aequor (Tampa, FL)
- …tax compliance and reporting for the region, encompassing transfer pricing documentation , intercompany transaction analysis, and tax provision support . This ... schedules for permanent and temporary items to ensure accurate reporting. Preparer documentation to support the analysis of profitability templates and defense… more
- Merck & Co. (Rahway, NJ)
- …Drug Product and Clinical Finished Goods).- - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as ... supply chain documentation to support critical CMC activities . - Responsible for authoring the Clinical Supplies section of the study protocol as well as… more
- Merck & Co. (Rahway, NJ)
- …requested by Product Development Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as ... supply chain documentation to support critical CMC activities. - - Support the collection of clinical supply chain metrics and/or participate in critical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, ... computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This… more
- Repligen (Waltham, MA)
- …in the preparation of internal and external financial reporting, including SEC filings support (10-Q, 10-K)Maintain documentation to support SOX internal ... control complianceParticipate in audit requests from internal and external auditorsSupport accruals, prepaids, fixed assets, and other assigned accounting areasAssist in implementing process improvements and enhancing operational efficiencyCollaborate with… more
- Aequor (Athens, GA)
- Tech-savvy information management specialist to support GI Development sites / activities. Major activities include: the subject matter expert for electronic ... documents, regulatory submission documents): Create and configure document templates and support site users in workflow configuration. Provide routine user … more
- Merck & Co. (Rahway, NJ)
- … such as master inventory lists, qualification documentation , calibration documentation , computer system inventories Support internal and external quality ... audits and maintain laboratory state of permanent inspection readiness Author or contribute to Standard Operating Procedures (SOP) draftingOriginate and own Investigations and Change Management recordsThe successful candidate must function both independently… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist, Sun-Wed 2nd Shift as part of the Technical Operations ... team based in Raritan, NJ. Role OverviewThe Operations Support Specialist will be part of the Technical Operations team responsible for the production of a… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …This role will be part of our manufacturing downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for assisting ... Engineer I will work alongside Process Associates and Process Scientists to support day to day issues in manufacturing related to: deviations, equipment… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to experiment with us? The Position The Senior Manager, Patient Support Data Intelligence is responsible for process improvement, technology, analytics, and ... reporting initiatives across the NovoCare® Patient Affordability and Access Support Platform. Oversight, maintenance, and ongoing enhancements related to the Patient… more
- Merck & Co. (Durham, NC)
- …Technician is responsible for providing equipment troubleshooting and maintenance support to VMF Operations areas (sterile supply, weigh/dispense, media, ... production equipment in a clean room environment. Responsible for written documentation of activities.- Actively supports, participates and embraces an empowered… more
- Merck & Co. (Rahway, NJ)
- …Information Management organization.Primary area of responsibilities will include:Project support for System Development, Maintenance, Enhancement and System ... pathways to ensure limited impact to delivery timelines for workstream activities. Support the development of User facing System Resources ensuring supporting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily ... to the supply network and existing commercial products undergoing process optimization. Support is inclusive of both start-up operations (FLEx Sterile1) and new… more
- Merck & Co. (Durham, NC)
- …Technician is responsible for providing equipment troubleshooting and maintenance support to VMF Operations areas (sterile supply, weigh/dispense, media, ... production equipment in a clean room environment. Responsible for written documentation of activities.- Actively supports, participates and embraces an empowered… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This ... for coordinating the authoring, review and approval of new or updated procedural documentation . In addition, this role will work closely with process owners, subject… more
- Eisai, Inc (Exton, PA)
- …pilot plant, including scheduling of staff, preparation and close-out of documentation , manufacture of DS/ADI materials, and suite change-over ensuring compliance to ... validation protocols and reports, and SOPs, along with providing supporting documentation . They formulate the overall strategy for Upstream and Downstream Operations… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, start-up, conduct and close-out) ... the direction and supervision by study Clinical Operations Lead(s). Plans, support , creates, and communicates clinical study timelines. Gathers input from… more
- Aequor (Davie, FL)
- …equipment troubleshooting. Execute planned maintenance and corrective work orders. Support to equipment, utilities and process troubleshooting / repairs. Responsible ... Perform technical documents, SOP updates and change controls. Provides ongoing support to maintenance staff to solve complex problems, understand and coach… more
- Merck & Co. (Rahway, NJ)
- …drive overall success and performance of the building, and ultimately strong support for the overall SM PR&D pipeline. Responsibilities: Under the scientific ... of the facility.Ensure facility readiness with respect to cleaning (including documentation and execution), dummy run and batch execution, building housekeeping, and… more
- Merck & Co. (Durham, NC)
- …warehouse operations and efficiency.- Additional responsibilities will include qualification support of off-site warehouse facilities for ambient and -70 storage ... Logistics and Operations managers and personnel as a subject matter expert (SME) in support of training and implementation of any new projects.- This includes SME … more
