- Daiichi Sankyo, Inc. (Bernards, NJ)
- …periodic review for controlled proceduresEnsure global and cross-functional consistency of process documentation to the extent possible by coordinating reviews ... research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs… more
- Aequor (Thousand Oaks, CA)
- …Manager, this role will be pivotal in identifying, documenting, and adapting documentation and process flows to support system and procedural transitions ... deep understanding of existing and future-state supply chain and manufacturing process flows as they relate to ERP implementation. Collaborate with cross-functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Inspections, filing of Submissions, and IRs.Maintain global master batch record and documentation on the platform process description and collaborate to the ... treatment of multiple myeloma.Legend Biotech is seeking a Global Process Steward as part of the Technical Operations team...for all technical scope for the approved Carvykti commercial process and overall program within Legend and with our… more
- Merck & Co. (Rahway, NJ)
- …team.Author protocols, reports, create drawings and specifications to ensure proper documentation of process development activities in accordance with relevant ... Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops… more
- Merck & Co. (Durham, NC)
- …teams to advance projects goals and deliverables related to the vaccine process Lead technical studies and author documentation associated with site ... technical reports and risk assessments Author or approve Change Control documentation for complex process , validation, analytical, equipment, facility/utility… more
- Merck & Co. (Rahway, NJ)
- …in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process developmentTrack record ... -scientific leader with expertise in downstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within… more
- Merck & Co. (Rahway, NJ)
- …in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process developmentTrack record ... for problem-solving and expertise in upstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Principal Scientist.BPR&D within Research… more
- Apex Systems (Acton, MA)
- …receive patient related documentation . This role is an essential part of the documentation process and will work directly with all teams to ensure all ... documentation to the appropriate department, open/scan and distribute mail and process Training Documentation from our Clinical Specialists. This role will… more
- Repligen (Rancho Dominguez, CA)
- …manufacturing, with deep expertise in Tangential Flow Filtration (TFF) systems, process engineering, and equipment qualification, preferably within GMP or ISO 9001 ... manufacturing systems. Lead projects in equipment design, tech transfer, process validation, and facility upgrades. Conceives, plans, and executes projects… more
- Merck & Co. (Rahway, NJ)
- …Expertise in independent ly conducting and directing the design, execution, analysis, and documentation of all stages of purification process development - Track ... penchant for problem-solving and expertise in downstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Principal Scientist.- - BPR&D… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …The Position This role will be part of our manufacturing downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for ... instrumentation and equipment start-ups from the laboratory through manufacturing scale. The Process Engineer I will work alongside Process Associates and … more
- Merck & Co. (Rahway, NJ)
- …in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.Experience ... (CPD), technology transfer (TT), scale-down model qualification (SDMQ) and process characterization (PC).Experience authoring technical documentation in support… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and equipment troubleshooting to support deviations, corrective actions ... and validation activities of new equipment and systems, including documentation of IQ/OQ protocols, test executions, and summary reports...in design and hazard reviews of plant expansions or process changes and serving as the technical point of… more
- Aequor (Tampa, FL)
- …and external teams to gather and disseminate relevant tax compliance documentation . Continuous Improvement Identify opportunities for process improvements in ... tax compliance and reporting for the region, encompassing transfer pricing documentation , intercompany transaction analysis, and tax provision support. This position… more
- CoreWeave (Bellevue, WA)
- …IT and business teams to implement scalable systems and controls. Lead process design, documentation , training, and adoption efforts across accounting. Manage ... long-term success. About the Role: As the Record-To-Report (RTR) Process Cycle Manager , you will be a key..., you will be a key driver of accounting process optimization and automation across the RTR lifecycle. You'll… more
- Merck & Co. (Rahway, NJ)
- …of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience strongly preferred, and experience with ... IT Business Partners including activities relating to Requirements Gathering, Documentation , Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee… more
- Merck & Co. (Durham, NC)
- …BCG Product. The position will focus on environmental monitoring, aseptic process simulation and support testing readiness in preparation for commercial production.- ... The selected candidate will participate in equipment validation, process validation, and GMP laboratory readiness.- The Quality Operations Laboratory Specialist… more
- Repligen (Hopkinton, IA)
- …role is responsible for assisting the document control department in processing documentation requests. They will work closely with cross-functional teams and within ... also serving as a resource for the review of quality documentation received from interdepartmental sources.ResponsibilitiesWorks with subject matter experts, area… more
- Merck & Co. (Rahway, NJ)
- …a GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and Development (SM PR&D) organization. The SSO pilot plant ... of new manufacturing technology/processes, training opportunities for improved manufacturing process development, and seamless technology transfer to commercial sites.The… more
- Merck & Co. (Millsboro, DE)
- …record keeping including charts, log books, and all pertinent documentation .-Identifies and addresses compliance, environmental, safety, and process ... Documentation , Manufacturing Operations, Manufacturing Quality Control, Media Preparation, Process Improvements, Regulatory Compliance, Safety Practices, Science, Standard Operating… more
