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The EHS Specialist Service Provider serves an important and highly visible role helping to ensure that site HSE Management System (HSE-MS) requirements are appropriately implemented and maintained necessary to ensure safe site operations.
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Utilization of security case management system to supervise and maintain logs of all investigations, site inspections, and open action items. Candidate must have a strong background in all major security domains to include physical security, risk assessment, investigations, travel security, threat management, executive protection, and protective intelligence.
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Bachelor’s Degree in Life sciences, including a min of 8 years in CDM, leading critical oncology or immunology projects from startup to database lock, adept at handling data for regulatory submissions, and proficient in Veeva EDC system management with a solid scientific educational background.
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The position is responsible for product development, technology transfer and overall management of CMC activities related to ensuring robust development and reliable GMP supply of oligonucleotide conjugates and intermediates.
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Expertise in primary human cell culture, multi-color flow cytometry, multiplex cytokine detection, functional immune cell assays (proliferation, cytotoxicity, chemotaxis) and assay development is essential.
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Lead, develop and manage the execution of role-specific and soft skills training to support the development of senior regional directors and district business leaders responsible for engaging with key accounts or hospital systems; launch and supervise the account engagement training program.
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Reporting to the Director, Process Development, the Associate Director of Cell Culture Process Development is responsible for the management of cell culture and cell line process development to advance drug substance through development and commercialization.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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Collaborate with Research teams to bridge non-clinical data into clinical development, and establish credible, clinically based biomarker, and cellular kinetics plans, as well as clinical data review.
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Strong candidates will have a track record working with challenging protein targets and/or multi-protein complexes to enable hit finding assay development. PhD in Biochemistry, Biophysics, Structural Biology or related discipline with 2-3 years of relevant postdoctoral training.
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Demonstrated track record of strategic leadership, team management, and organizational development. Strategically set people goals including internal career development and talent management as well as alternative resourcing strategies, where needed.
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Lead and/or support TMF creation and/or TMF system implementation and configuration including the development ofTMF management plan(s). Expertise in clinical trial documentation and TMF Reference Model filing structure and proficient in eTMF systems or other Electronic Document Management System (familiarity with the Kivo system is a plus.
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Experience in all stages of analytical development and product characterization from preclinical through product licensure, including intra- and inter-company technology transfers, CRO/CDMO management, and the evaluation of novel analytical technologies.
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The Systems Engineering, Integration, And Test (SEIT) Department Of Boston Dynamics (BD) Seeks a Technical Leader And Manager Who Will Advance State-of-the-art Verification, Validation, And Test (VV&T) Systems For The Most Capable Humanoid Robot System In The World.
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U.S. federal agencies include the Army Corps of Engineers, Air Force, Navy, Coast Guard, National Park Service, Federal Law Enforcement Training Center, Customs and Border Protection, Fish and Wildlife Service and the Department of State.
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training and development management system jobs in Natick, MA
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