- Aequor (South San Francisco, CA)
- …dependencies contributing to end to end RBQM delivery Technical Skills Proficient in data analysis tools (eg, R, Python, JMP) for manipulating, analyzing large ... management to facilitate the study start-up planning. We develop advanced analytical data visualization and conduct predictive analysis to increase the… more
- Merck & Co. (South San Francisco, CA)
- …development and for further hypothesis testingEmploy best reproducible research and data integrity practices to generate reusable analysis frameworks for ... readoutsDemonstrated expertise in the application of methods of statistical learning and data mining for the integrative analysis of high-dimensional molecular… more
- Merck & Co. (Rahway, NJ)
- …throughput experimentation using automation platforms such as TECANExperience using and/or programming process control systems such as DeltaV and PCS 7Experience ... approaches related to downstream processes and predictive modeling (multivariate data analysis , machine learning/artificial intelligence, leveraging PAT)NOTICE… more
- Merck & Co. (Rahway, NJ)
- …and analytical inputsIntegrate unit operations both physically and with relevant process control and monitoring platforms for concurrent operationsCollaborate ... protein purification, biochemical engineering, or protein analytical technologiesKnowledge of statistical data analysis tools such as the design of experiments… more
- Merck & Co. (Rahway, NJ)
- …in media/solution development and chemistryHigh-throughput experimentation, automation, and process control .Knowledge of microbial fermentationCell culture ... execution, analysis , and documentation of all stages of cell-culture process developmentTrack record of accomplishments in upstream bioprocessing with a history… more
- Merck & Co. (Rahway, NJ)
- …and advanced in situ analytics for process monitoring and control .Expertise in media development, media/solution chemistry.Background in data science ... Job DescriptionThe Biologics Process Research & Development organization within our Company...and oral communications abilities. A track record of leveraging data science and digital tools for delivering impactful solutions… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …include verification protocol execution (FAT, SAT, DQ, Commissioning, IQ, OQ, & PQ), data analysis and final report preparation Participate in the development ... coordination with appropriate teams Support facility certification for new Manufacturing ( process equipment & facility-support equipment) and Quality Control … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …May require utilizing tools beyond Excel, such as SQL, Python, R, or specialized data analysis software for in-depth analysis . Ensuring the accuracy, ... business opportunities and problems that can be solved using data analysis . Pro-actively streamlining processes and deliverables...BI, R, or similar) Strong attention to detail, quality control and problem-solving using big data General… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as a liaison with the external partner for a smooth consolidation process . Also responsible for managing various studies including late-stage budget and forecasting, ... analysis , strategic planning, internal reporting, and ad hoc reporting...early phase to late-stage clinical studies. Accountable for the control and reporting of GEMRAD approved budgets. On a… more
- Aequor (Thousand Oaks, CA)
- …accuracy of experimental data contained in written reports against final summary analysis files and ELN, eg, QC of text, tables and figures. Confirm that ... will be an office based role, utilized for quality control of the instruments the Scientists are using. We...data verification) Coordinate, organize and support the QC process by accessing multiple internal databases (eg, ELN, CDOCs,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with the FDA and other regulatory agency audits. Serve as an Internal Auditor. Data Management- perform statistical data analysis and prepare reports.pFMEA- ... overseeing the health of the manufacturing processes. This starts with proper risk analysis in manufacturing design, then goes into addressing risk in process … more
- Merck & Co. (Durham, NC)
- …Expert (SME) for areas of responsibility.Develop and report to senior leadership data analysis and metrics to ensure systems' compliance and performance.Serve ... control impact assessments. Proven expertise of cGMPs, technical writing, data management collection, and analysis .- Demonstrated Quality, Technical, and /… more
- Lundbeck (Bothell, WA)
- …and regulatory submission documents Provide cross-functional support to upstream/downstream process development, formulation, and quality control teams ... Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global… more
- Merck & Co. (Rahway, NJ)
- …scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications.Ability to design, ... in the pharmaceutical industry.-Required Experience and Skills:Extensive experience in analysis of biologics (separation methods such as Size Exclusion… more
- Merck & Co. (Rahway, NJ)
- …and discrepancies as data stewards responsible for qualification, data analysis , creation, modification and change control for SAC-P (SAP Analytics Cloud ... expertise with SAC Analytics technologies, including Datasphere, SAP BW, HANA, Master Data management and ECC.Maintain FP&A planning process on monthly/quarterly… more
- Merck & Co. (Rahway, NJ)
- …the following:Experience performing lab-based crystallization development and/or solid-state analysis .Experience with process scale-up and technology transfer ... with crystallization Process Analytical Tools (eg, FTIR, FBRM, Raman, image analysis ), common off-line analytical techniques (eg, HPLC, GC, SEM, NMR), and … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... with us? The Position To effectively support and manage the financial close process of Novo Nordisk Inc. and other legal entities under the commercial sales… more
- AUROBINDO (Durham, NC)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control , and regulatory affairs. In addition to several formulations under manufacture, ... the pharmaceutical industry. Proficient in LC-MS/MS techniques for the analysis and characterization of Nitrosamine/NDSRI impurities and small molecules. Expertise… more
- Merck & Co. (Rahway, NJ)
- …documentation in support of the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, ... state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.Background in data science approaches related… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Liaison between Production Support and Manufacturing for the coordination of process /equipment improvements and data trending/ analysis Review/approval of ... Ability to investigate and write up Deviation events utilizing Root Cause Analysis Incorporate pre-planned process improvements and cost reduction projects into… more
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