- 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
- 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. (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
- Twist BioScience (South San Francisco, CA)
- …and convert them into Salesforce features and configurations. Create detailed documentation including business process flows, user stories, solution designs, ... CRM solutions. This role requires a deep understanding of CRM strategy, process design, data architecture, and cross-cloud integrations. The ideal candidate is both… 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
- 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
- Merck & Co. (Durham, NC)
- …production equipment in a clean room environment. Responsible for written documentation of activities.- Actively supports, participates and embraces an empowered ... between Mechanical Service Engineer (MSE) and Operations.Review work order documentation .Accountable for work order proper handling.Train other mechanics on… 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
- 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. (Durham, NC)
- …production equipment in a clean room environment. Responsible for written documentation of activities.- Actively supports, participates and embraces an empowered ... projects that help improve the business by streamlining workMaintains process equipment by developing/performing PM's, installing new equipment, documenting work… more
- Merck & Co. (Rahway, NJ)
- …products, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the ... supply network and existing commercial products undergoing process optimization. Support is inclusive of both start-up operations (FLEx Sterile1) and new capital… more
- Merck & Co. (Rahway, NJ)
- …activities for System Development Life CyclePrepare, review, and approve documentation such as master inventory lists, qualification documentation , ... company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an… more
- Merck & Co. (Rahway, NJ)
- …The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical development, ... requested by Product Development Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply… more
- Merck & Co. (Rahway, NJ)
- …The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical development, ... Product and Clinical Finished Goods).- - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply… more
