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The candidate will be a part of the Biologics Drug Product Development team in support of Gene Therapy programs in the Genomic Medicine Unit. The incumbent will have the opportunity to work on different facets of drug delivery and product development for modalities such as Lipid Nanoparticles (LNPs) and Adeno-associated virus (AAV.
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The Scientist II will provide technical leadership in complex in vitro and in vivo workflows, identification and validation of new drug targets, advancing novel therapies, and developing technologies to accelerate scientific research.
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Responsibilities Support the development of the Drug Substance strategy and oversee manufacturing of preclinical and clinical material. Senior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team.
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10+ years of experience in drug safety/pharmacovigilance within global clinical trial settings, with expertise in FDA, EU, ICH regulations, and Good Pharmacovigilance Practice guidelines. Demonstrated proficiency in drug safety databases (e.g., Argus), electronic data capture systems, and coding with MedDRA and WHO Drug dictionary.
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Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curiosity, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory, Lifesciences, Machine Learning (Ml), Management, Medical Research, Molecular Biology {+ 10 more.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Qualified candidates must have a PhD in synthetic/organic chemistry or related scientific field with 15+ years’ experience in drug substance development and manufacturing and a proven track record in developing and scaling up chemical process to kilo lab, pilot plant and commercial plant scales.
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Job Overview : The successful candidate will provide deep expertise in protein and peptide bioanalysis to support the advancement of projects across multiple drug discovery programs. Independently and collaboratively identify and deliver high quality drug candidates based on protein/peptide conjugation.
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Principal Scientist II, Drug Discovery – Kidney Diseases. Contribute to the Biomedical Research drug discovery process with the goal of progressing the development of new therapeutic options for patients with chronic kidney diseases.
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Keywords: Cheminformatics, Computational Chemistry, Machine Learning, Artificial Intelligence, Computational Sciences, Drug Discovery, Pharmaceutical, Biotechnology, Boston, Cambridge, Massachusetts.
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Are you passionate about creating intuitive and user-centered interfaces that empower scientists to accelerate drug discovery and development? Be part of a groundbreaking initiative that accelerates drug discovery and development.
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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. In conjunction with the CRO, identifies required study specific training of the clinical staff, ensuring understanding of the drug development process and knowledge of international standards (GCP/ICH), the requirements and compliance with the appropriate health authorities (FDA/EMEA), and the application of the aforementioned to the entire study.
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Support Elektrofi pilot plant unit operations to provide robust manufacturing procedures used to process monoclonal antibody drug substance and drug product for IND enabling studies. This role will work on technology transfer projects to introduce new drug substances to the pilot plant process.
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The Principal Toxicologist will be responsible for the design and execution of nonclinical development toxicology studies conducted externally, interpretation and communication of the toxicology data/reports to support drug development decisions, and for summarizing and writing regulatory submissions.
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Experience in therapeutic drug discovery, gene therapy or RNA therapeutics. Experience in therapeutic drug discovery, gene therapy or RNA therapeutics. Experience with ELISA/ WB, IHC/ Immunofluorescence and microscopy is a plus.
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drug job in Woburn, MA
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