- Merck & Co. (Rahway, NJ)
- …and Collaborate:-Join dynamic teams focused on late-stage commercial process development, process characterization, and technology transfer, ... and commercialization.Lead Laboratory Studies:-Conduct laboratory-scale studies that support commercial process validation and characterization, whether in-house or through external… more
- Merck & Co. (Millsboro, DE)
- …our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality and cost-of-goods ... and deliver measurable results.What you own: Lead and grow the Integrated Process Team (IPT) - coach managers and individual contributors, build capability, and… more
- Merck & Co. (Rahway, NJ)
- …experiments independently.Ability to direct the planning, execution, analysis, and documentation of all stages of downstream process development.Ability ... Job Description Associate Principal Scientist The Biologics Process Research & Development organization within our company's Research Laboratories is responsible for… more
- Twist BioScience (South San Francisco, CA)
- …requirements and convert them into Salesforce features and configurations. Create detailed documentation including business process flows, user stories, ... 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
- 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 ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Global Process Steward as part of the Technical Operations team based in Raritan, NJ.… more
- Aequor (Tampa, FL)
- … process documentation with the ability to deliver high-quality process maps, assessments, and related business materials. The primary responsibilities ... Time Preferably with more than 3 years of experience, especially in finance, payroll, business process management, and supply chain. 3&plus years' experience in … more
- Merck & Co. (Lower Gwynedd, PA)
- …, Laboratory Information Management System (LIMS), Oral Communications, Process Improvements, Quality Auditing, Regulatory Communications, Regulatory Compliance, ... processes and procedures. -The candidate will participate in data reviews or process inspections to ensure generation of quality data, maintain metrics associated… more
- Merck & Co. (Lower Gwynedd, PA)
- …BA organization through management of standard operating procedures (SOPs), and training documentation , ensuring staff have the tools and skills to perform job ... areas, including the biological sciences, computer sciences, medical technology, business management, etc.-Responsibilities-Strong knowledge of document or training management… 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
- Merck & Co. (Lower Gwynedd, PA)
- …required for regulatory filings. The compliance team will ensure all operations, documentation , procedures, and filings meet all regulations and will focus on both ... responses. --Conducts review of all laboratory data to drive high quality documentation , data integrity, staff adherence to procedures-Leverages IT tools to develop… more
- Merck & Co. (Rahway, NJ)
- …timelines for site, filing, and launch readinessImproved access to product and process dataStreamlined transfer of process and product knowledge with reduced ... to create a frictionless flow of data from source systems to regulatory documentation .- Under the guidance of dCMC Leadership, the Senior Specialist, Digital CMC… more
- Merck & Co. (Rahway, NJ)
- …and validation.Working knowledge of analytical test method technology transfer process .Skilled in laboratory good documentation practices and electronic ... strategies for innovative combination products?Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design, development, and… more
- Aequor (Thousand Oaks, CA)
- …regulated operations. Work closely with internal and external project team members, including business process owners and functional SMEs, to enable successful ... Manager, this role will be pivotal in identifying, documenting, and adapting documentation and process flows to support system and procedural transitions… more
- Merck & Co. (Lower Gwynedd, PA)
- …, Laboratory Information Management System (LIMS), Laboratory Investigations, Process Improvement Projects, Project Management, Regulatory Compliance, Regulatory ... in technical writing, including the authoring of procedures, regulatory or audit responses, process flows, and a variety of reports, including but not limited to… more
- Merck & Co. (Rahway, NJ)
- …to GMP procedures, strong attention to detail in completing GMP documentation , proficiency in electronic systems, and participation in continuous improvement ... ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business . Responsible for establishing a Right First-Time culture by reducing waste… more
- Merck & Co. (Durham, NC)
- …aptitude, and actively contributes to team performance and process improvements.Key ResponsibilitiesOperational Proficiency:Fully qualified to independently operate ... chromatography columns, washers, autoclaves, or Clean-In-Place (CIP) systems.Compliance and Documentation :Takes ownership of cGMP compliance, ensuring adherence to Standard… more
- Merck & Co. (Rahway, NJ)
- …Global Development Quality Operations, is responsible for independent approval of documentation to support GMP clinical supply drug product manufacture, testing, ... clinical supply programs. This person will also independently approve documentation accompanying the disposition of excipients, components, and critical supply… more
- Merck & Co. (Durham, NC)
- …troubleshooting.- This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent ... are guided by policies, procedures, engineering design guidelines and business plan; receives guidance from manager when necessary.Provides & Implements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as Quarterly Quality Reports (QQRs) and Quality Review Boards (QRBs).Collaborate with business process owners to monitor the effectiveness of clinical ... that any gaps or risks are addressed with continuous improvement initiatives.Work directly with business process owners to integrate quality into all stages of … more
- Merck & Co. (Rahway, NJ)
- …qualification or advancement to a higher classification. Must practice proper and documentation requirements.Work Performed:Operates 900 #, 400 #, and 135 # steam ... Starts, stops and operates all boiler auxiliaries (fans, pumps, etc.) Performs in- process control tests on boiler and heater water. Using the control tests… more
