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Position Summary: The Director, Clinical Systems and TMF Operations is a member of the Clinical Business Operations team within the Development Operations organization and is responsible to provide strategic leadership and oversight of Trial Master File (TMF) Operations, Records Management, and Clinical Systems & Technology (CS+T) utilized across clinical programs.
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Serve as the analytical subject matter expert (SME) for internal product development, employing a range of analytical techniques such as chromatography (HPLC, UPLC, SEC), mass spectrometry (LC-MS), and other standard methodologies to support preclinical stage large molecule projects.
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The ideal candidate for this position should have work experience in cell therapy process development, manufacturing science, analytical development, and familiarity with GMP/FDA/ICH guidelines.
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Today, the Life Skills program provides personal and career-development services to young adults with autism. Teach and assist in the development of learners instruction and treatment goals with special emphasis on home and community-living skills, social skills, language and communication skills, physical fitness, and employment skills.
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Represents department in business development due diligence and partner alliance management as appropriate; sits on JDC/JRC/JSC as appropriate. Oversees and/or designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies.
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Our team utilize the most cutting edge biomarker technology to support a wide range of clinical trials for BMS drug development in areas including oncology, immuno-sciences, cardiovascular, and neurology.
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Maintain thorough understanding of current regulatory guidelines and requirements relevant to rare disease drug development. Extensive working knowledge of FDA regulations, ICH GCP guidelines, and the drug development process.
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Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.
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ML, NLP, LLM Model Evaluation: Work closely with the other data science team members to develop, validate, and maintain robust evaluation solutions and tools to evaluate model performance, accuracy, consistency, reliability, during development, UAT. Implement model optimizations to improve system efficiency.
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The Senior Scientist, Cell Therapy Process Development is responsible for development and technology transfer of internal and client related projects. The cell therapy process development team at is actively looking for a Senior Scientist, Cell Therapy Process Development contributing to the development of early and late stage clinical cell therapy manufacturing processes.
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This is a multi-faceted role where the Technical Talent Development Manager will drive the Talent Management process and develop strategies to improve the onboarding of new employees, skills assessment, and career development through training, project opportunities, and certification.
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Learn from our educational seminars given by our Directors on topics including but not limited to: international development, NGO/social enterprise creation and management, marketing and outreach, research techniques and more.
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ML, Gen AI, NLP, LLM Model Development: Design and develop custom ML, Gen AI, NLP, LLM Models for batch and stream processing-based AI ML pipelines. Experienced with NLP, LLMs (extractive and generative), fine-tuning and LLM model development.
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The Grants and Development Communications Manager is the lead grant writer for foundation and government grants and manages an existing portfolio of 70+ institutional donors, as well as pursuing new institutional.
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The Senior OnBase Developer is responsible for the support, development and integration of solutions deployed on the OnBase by Hyland enterprise platform. Differentiate configuration between controlled environments and migrate changes through the development lifecycle, per established dev/ops procedures.
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