- Formation Bio (New York, NY)
- …who thrives on technical depth, mentorship, and platform thinking. You'll lead the design of scalable systems that transform both structured and unstructured ... strategy initiatives. AI Data Engineering & Unstructured Data Workflows Design and operationalize pipelines for classification, entity extraction, summarization, and… more
- Merck & Co. (Rahway, NJ)
- …specific experience in autoinjectors, prefilled syringes, and complex drug delivery systems .Proven expertise in design controls, risk analysis, control ... focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers...needs of manufacturing are considered as part of the design .- Provide information and drive early alignment and readiness… more
- Merck & Co. (Rahway, NJ)
- …delivery product design and delivery device technologies, including the design requirements of the associated primary container systems .Strong external ... extensively with subject-matter experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly… more
- Merck & Co. (Rahway, NJ)
- 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 ... clinical and commercial assembly equipment and processes for medical devices/drug delivery systems . Reporting to the Director responsible for this area, you will… more
- Twist BioScience (South San Francisco, CA)
- …Assurance, Process Development, and Regulatory Affairs teams to define MES requirements, design seamless integrations with other enterprise systems (eg, ERP, ... for our custom MES, including detailed requirements gathering, system design , coding standards, development, rigorous testing, validation, deployment, and… more
- Twist BioScience (South San Francisco, CA)
- …and driving teams to achieve aggressive goals. Experience with ISO 13485 design control and Quality Management Systems .Superior interpersonal skills and ability ... will have an opportunity to help shape the team's systems and processes as we continue to scale with...minutes) accordingly.Leads projects and team members through ISO 13485 design control process; creates and maintains a high-quality DHF.Builds… more
- Merck & Co. (Rahway, NJ)
- …power chains (including UPS systems , ATS, backup generators, RPDU's), HVAC/CRAC systems , fire detection and protection, white space design , and other ... the delivery of Technology Space products and services globally.ResponsibilitiesSupport design and delivery of Technology Spaces for new builds, renovations,… more
- Merck & Co. (North Wales, PA)
- …responsible for Portfolio Real-world Evidence (RWE) in Oncology.- -Position objectivesTo design and execute real-world evidence studies, designed to demonstrate the ... regulators, health care providers, HTAs, patient organizations, and othersTo design and implement outcomes research studies, in collaboration with scientific… more
- Merck & Co. (Rahway, NJ)
- …as a liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business Requirements and ensuring ... and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: Monitor user support cases, ensuring proper investigation… more
- Aequor (Thousand Oaks, CA)
- …demonstrating capabilities & new ways of working, to assist in the design and implementation of both new technologies, new processes.Job Description: Clinical Trial ... knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design , Risk-based Quality Management etc. Determine key performance indicators (KPIs)… more
- Merck & Co. (Rahway, NJ)
- …techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop ... analysis, or a related field.Experience developing and maintaining Building Management Systems (BMS) and Building Automation Systems (BAS), including Historian,… more
- Merck & Co. (North Wales, PA)
- …to meet the value evidence needs of payers, advisory committees health systems , and clinicians.The incumbent can generate these plans based on direct interactions ... HTA/reimbursement needs for the product and gain input on research design and implementation of retrospective database studies, assessment of patient reported… more
- Merck & Co. (Rahway, NJ)
- …studies to support commercial process validation and characterization. You'll design experiments, analyze data, and mentor junior staff, ensuring excellence ... in the purification of biological molecules, including chromatography and filtration systems .Technology Transfer Experience: Proven track record in tech transfer or… more
- Merck & Co. (Rahway, NJ)
- …capabilities in structure-based modeling, predictive science, and AI/ML to drive drug design and development globally, with a proven track record of pipeline impact. ... to impact all aspects of the early target discovery, including library design , tool compound selection, and target prioritization, etc.Analyze and integrate internal… more
- BioAgilytix (Durham, NC)
- …from core systems (LabVantage LIMS, ERP) into a centralized data repository. Design and implement the architecture for a scalable data hub, using cloud platforms ... integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA. Design data quality KPIs and implement initial quality checks independently,… more
- Repligen (Clifton Park, NY)
- …single-use state-of-the-art single use components and innovative storage and transfer systems that optimize fluid transfer and reduces the number of connections ... This role requires in-depth knowledge and experience of manufacturing solutions and systems as well as solves complex problems and takes on new perspectives… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to one of our manufacturing suites. Responsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start-ups from ... start-up, verification and validation activities of new equipment and systems . Responsibilities include verification protocol execution (FAT, SAT, DQ, Commissioning,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... guage effort, and deliver robust, right first time EBR designs.Participate in design testing, release planning, and demos with partners.Serve as a Subject Matter… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …curriculum in areas of general use, foundational and core skills, systems , unit operations and aseptic processingPrepares and maintains training lab, materials ... an aseptic manufacturing facility, preferably in training/system applications, quality systems , or learning management systems .Knowledge of cGMP regulations… more
- Merck & Co. (North Wales, PA)
- …submissions and post marketing support.The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups ... clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.Experience leading large and/or complex statistical… more
