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Contribute to product development from Research to Commercialization by collaborating with multiple functions within the Pharmaceutical Science organization to improve analytical, process and product knowledge.
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Principal Scientist – mRNA Process Development Scientist/Engineer. We are seeking a highly motivated and experienced mRNA Process Development Scientist/Engineer to join our dynamic team.
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Minimum of 10 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug products under cGMP's. Benchmarks current trends within industry for all areas within Analytical Controls also including strategic development and planning of system architecture in alignment and collaboration with partners and stakeholders e.g. GMS/GQ for company wide systems, IT and PSST for new solutions.
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Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all project-related analytical control topics, development requirements and program milestones including global reporting.
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Ability to integrate public policy advocacy with public affairs, communications, business strategy and corporate development. As a member of Google’s Government Affairs and Public Policy team, you'll be part of a diverse global government affairs team, working across regions, product areas, and functions.
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The successful candidate will participate in ongoing assay development and drug discovery programs in neurodegeneration. The work will focus on mammalian tissue culture work and will involve development of gene expression assays using signal transduction readouts, protein analysis using immunocytochemistry, western blotting and high throughput microscopy.
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PhD in Analytical Chemistry with 6+ years in CMC analytical development for small molecule Drug Substance and Drug Product. Job Overview: The Principal Scientist in Analytical Development guides pharmaceutical advancements from inception through clinical stages and collaborates with internal and external partners.
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The individual will be responsible for TM and clinical biomarker activities to support drug development programs in neurodegeneration and neuropsychiatric indications. Responsibilities will include, but are not limited to, the following:Designs and implements program-specific late development biomarker/translational plans, responsible for aiding in creation of clinical protocols, SAPs, SOWs, lab manual, and interfacing with CRO for execution of services, in conjunction with Biospecimen Operations and Procurement.
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Reporting to the SR Director, Drug Product as part the CMC Technical Operations team the Principal Scientist, Drug Product, will provide strategic and technical leadership within the CMC Technical Operations to support the development and optimization of Akebia's clinical and commercial programs.
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Company is currently seeking an Analytical Chemist in our Pivotal Attribute Sciences Department in Cambridge, MA. This team plays a crucial role in pivotal phase analytical support, including product development support, testing of drug substances and drug products.
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Because of our investments in public cloud infrastructure and machine learning platforms, we are now uniquely positioned to harness the power of AI. We are committed to building world-class applied science and engineering teams and continue our industry leading capabilities with breakthrough product experiences and scalable, high-performance AI infrastructure.
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Oversee CDMOs for phase-appropriate analytical method development, qualification, validation, and transfer for in-process testing, drug substance (DS) and drug product (DP) release and stability testing.
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Proficiency in experimental design, data analysis, and a range of biology skill sets including in vitro cell assay development, plate-based assays, Western blotting, protein quantification, ELISA, MSD, transfections, lentiviral transductions, siRNA/shRNA/CRISPR, qPCR, and viability assays.
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Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, edit check specifications, and data management plans identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF.
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Several years of experience within Immuno-Oncology, Oncology at the biotech/pharmaceutical and the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late stage development in Phase III and NDA submission.
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product development jobs Company: Biogen Idec in Cambridge, TN, Us
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