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The Senior Principal Scientist will collaborate across BMS sites with Analytical, Drug Product, Drug Substance, Quality, and Regulatory leads to execute drug product formulation/process development support, analytical strategies for drug product methods and specifications, analytical control strategies, and support of product development up to drug application submissions and approval.
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The candidate should have a strong track record in product development/ regulatory filing/ drug delivery/ complex formulation and process development/ characterization reflected through industry experience and external publications/ patent.
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Track record in drug discovery/development in large or small biotech/pharmaceutical companies, leading translational/biomarker studies or innovative efforts to deploy technologies and assays for enhanced translational capabilities or similar skill sets in academia.
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The Senior Principal Scientist role will be responsible for development and execution of drug and myeloma asset centric translational strategies in hematology for assigned programs. Translational Medicine Hematology at BMS has a long-standing history of scientific rigor as evidenced by our peer-reviewed publications, delivery of drug approvals including Revlimid, Pomalyst, Idhifa, Inrebic, Reblozyl, Vidaza and Onureg, strong academic collaborations and talent development.
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Deep understanding of drug development process, international drug approval procedures and standards (e.g., ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management (e.g., DIA TMF reference model.
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Minimum of 8 years of working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organization) with specific experience in clinical documentation and/or records & information management.
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Translational Medicine is part of the Global Research and Early Development organization in BMS and leads mid to late stage clinical, pharmacological, and translational research and development activities for the BMS hematology pipeline and supports late-stage portfolio for translational development and life cycle management.
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The Senior Principal Scientist will play an integral role as part of the drug product development organization and will provide necessary guidance and support of drug product control strategy for drug candidates across all stages of development and, as needed, within the commercial product portfolio.
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Strong knowledge of solid state NMR including application in the pharmaceutical industry, establishing new ssNMR methods, and prospectively impacting problems related to drug discovery, characterization, and development.
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It’s a customer focused senior application analyst position with an emphasis on analyzing business requirements, creating functional technical designs, and code development utilizing IDMS, DB2, VSAM and COBOL in a batch environment.
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Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical/biotech industry. This role will be the critical clinical and data partner for business development, marketing, and partnerships team members to anticipate biopharma, healthcare practitioners and payers needs in the space.
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Under the scientific direction of a facility lead, the Operations Specialist will participate in equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge capture, and troubleshooting equipment with the aim of advancing process development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development.
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We offer a comprehensive suite of offerings, including staffing and recruitment services, managed services, IT consulting, and project management, providing unparalleled opportunities for professional growth and development.
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The Group remains true to its three founding values: entrepreneurial spirit, mutual trust, and a strong sense of ethics, as illustrated by the 2030 Sustainability and Responsibility roadmap supporting the United Nations Sustainable Development Goals (SDGs), “Good times from a good place.
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PSEG offers a unique experience to our more than 12,000 employees - we provide the resources and opportunities for career development that come with being a Fortune 500 company, as well as the attention, camaraderie and care for one another you might typically associate with a small business.
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drug development jobs Company: Genoskin in Summit, NJ
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