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Must have direct experience in Regulatory Affairs CMC for biologics/vaccines or cell and gene therapies, with a demonstrated track record of significant accomplishments (e.g. successful IND, leading health authority interactions on CMC topics.
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Experience of working with multiple modalities ideally small molecules, ASOs, gene therapy, cell therapy and biologics. Reviews and approves regulatory documents and correspondence on behalf of DMPK.
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Biopharma CGT (Cell and Gene Therapies) is seeking a Senior Manager of Materials Operations to lead a team responsible of multiple GMP warehouses within Vertex’s internal Cell and Gene Therapy manufacturing network.
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The candidate will perform literature search about the newest trend and technology in Cell and Gene Therapy development, majorly focused on finding a way to make stable inducible host cells line to product viral vectors.
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Collaborate with business stakeholders and suppliers extensively on developing and implementing risk and resiliency strategies to ensure continuity of supply for innovative product pipeline, and expanding market footprintRegulatory Compliance, Stay abreast of regulatory requirements and industry standards related to cell and gene therapy sourcing.
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Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Communication, Curiosity, Data, Data Analysis, Design of Experiments (DOE), Detail-Oriented, Drug Development, Drug Discovery Process, Ethics, Gene Therapy, Group Problem Solving, Immunology, Inventory Management, Laboratory, Large Group Presentations, Leading Project Teams, Life Science, Machine Learning (Ml), Medical Research {+ 9 more.
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Ultragenyx is seeking an analytical chemistry scientist with a collaborative and innovative mindset to join our Analytical Development group in Woburn, MA. Strong preference will be given to a candidate with proven experience in developing biophysical assays like, AUC(Analytical Ultra Centrifugation), MALS (multi angle light scattering), HPLCs, CE-SDS, iCIEF, LC-MS as it relates to biologics and gene therapy products.
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Hands-on experience in tissue culture, plate-based assays, RNA isolation, gene expression analysis (qPCR), western blot, ELISA, multiplex protein analysis, flow cytometry preferred. Perform molecular techniques including DNA/RNA isolation, PCR, qRT-PCR, gene expression analysis, cell line engineering and tissue culture as needed.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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Strong understanding of the Pharma and Biotech industry challenges is needed and ability to develop high level of applications knowledge based on industry and familiarity with most common Sequencing, Synthetic Biology, cell and gene therapies, and molecular biology lab techniques.
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This client is a growing international full-service CDMO/CRO within the biotechnology space looking to aggressively expand its footprint in the US. The company has a strong base of API/Small Molecule, Biologics, Clinical Research, Bioanalytical Sciences, DMPK, Cell and Gene Therapy and other capability centers across the US. This business has developed a fantastic brand in the US through exceptional service which drives repeat business.
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Let us introduce ourselves If you're passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. As a Full Time Associate Director Medical Writing at Beacon Therapeutics (USA) Inc, you will work cross-functionally to play a pivotal role in developing and preparing scientific and regulatory documents for our ophthalmology pipeline.
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The Clinical Scientist is a Director/Senior Director who will help design and execute the clinical development plan for Affinia’s cardiac and neurology gene therapy pipeline. Affinia Therapeutics is an innovative gene therapy company with a vision to create a paradigm shift by broadening the reach of gene therapy to prevalent diseases.
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The associate scientist role supports the generation of AAV candidates for the company’s preclinical gene therapy pipeline. Responsibilities: Production and analytical characterization of AAV vector using mammalian cell culture Develop, optimize, and troubleshoot protocols for AAV production processes Maintain organized and detailed electronic records, submitted in a timely manner Report data to team members through written reports and direct collaboration Qualifications: Experience with viral vector production and cell culture techniques and are looking to expand your knowledge of AAV based gene therapies.
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Overview The (OEA) at Tufts University School of Medicine is primarily responsible for the medical school academic programs, curriculum design and delivery, system-wide evaluation, faculty development, interaction with the offices of Student Affairs, Registrar, and Professional Degree Programs, and promotion of academic excellence through grant participation for innovative programs.
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affairs gene therapy jobs Title: regulatory affairs in Boston, MA
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