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The Associate Director, Clinical Data Analyst, has a critical role in the delivery of high-quality external data across Dyne's development pipeline by proactively identifying, measuring, and mitigating risk prior to acquisition of non-electronic data capture (EDC) data.
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The Senior Analyst / Scientist will work cross-functionally with others in Quality Control, Analytical Development teams, Quality Assurance, and Manufacturing, as needed. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs) and analytical assays for AAV efficacy (potency), safety and product quality.
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Knoledge in Databricks, PowerBI, programing languages including SQL, Python and PySpark, data principles including data pipeline, streaming data, data storage, ETL, data integration, database design Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change.
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The Scientist, Analytical Development & Quality Control is responsible for analytical development, feasibility, method qualification, routine, and stability testing of antibody drug conjugates and intermediates.
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Partners with Research/Business Units, external DM service providers and internal CDS staff to deliver high quality data management for all studies as assigned. Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all CDS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence.
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We have a unique opportunity for someone to contribute their talents and strengths as an Indirect Tax Analyst. Indirect Tax Analyst to assist with day-to-day indirect tax work and special projects.
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A minimum of 3-5 years in Analytical Development and/or Quality Control preferably in a clinical stage biopharmaceutical company. Scientist, Analytical Development & Quality Control.
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The Lead of Quality Control and Analytical Development is responsible for managing a team that provides quality oversight in support of clinical and commercial operations and analytical development of early and late-stage clinical products.
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We are currently looking for an energetic and well-rounded Business Development Manager to join our growing team in Boston, MA. Developing relationships with customers and generating new business.
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QA review and approval of; Analytical Instrument Qualifications; Analytical Method Qualifications: API and Drug Product Specifications; API and Drug Product Stability Data; Master batch production records; Analytical records; Executed batch production records; Cleaning Verification Protocols; Quality Risk Assessments; GMP SOPs; approval of raw materials/API's and release for use.
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Performing annual account reviews, periodic reviews Performing GMP data quality assessments and managing deviations Managing document review and approval workflows in a global document management system Working with data archiving and electronic document management systems (in house systems are OpenLab and Veeva Quality Docs) Manage IQOQ and UAT – write and execute test scripts, author test summary reports.
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Entrepreneurial energy driving value ahead of demandStrong working knowledge of the intersection of technology strategy and the impact of new emerging technologies, such as data and analyticsDesired:Advanced degreeIn-depth Pharmaceutical industry and/or drug development experienceTakeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career.
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Skyworks is seeking a Product Quality Engineer to work in Woburn to support his growing automotive business. Show strong potential global leadership skills with proven ability to influence development teams to improve quality when faced with schedule/cost/performance tradeoffs.
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Its programs range from ground-based astronomy and astrophysics research to space-based research, the engineering and development of major scientific instrumentation for space launch and use in large ground-based facilities, and research designed to improve science education.
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Design toxicity studies: coordinate with Preclinical Outsourcing for placement and monitoring of the studies as well as the Bioanalytical and DMPK groups regarding integration of bioanalysis and toxicokinetic aspects into these studies to ensure on-time delivery of key data and study reports.
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business development analyst data quality jobs Company: Pnc in Burlington, MA
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