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Work closely with colleagues in Process development to design and implement new technologies for aseptic filling of cell therapy drug products in novel device platforms; this includes working closely with Contract Development and Manufacturing Organizations (CDMOs) and engineering firms to design processes and equipment needed to perform aseptic filling operations in a GMP environment.
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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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Experience with development of Cell and Gene Therapy or ATMP products, and bioassay requirements. Understanding of the evolving regulatory requirements for cell and gene therapy (OTAT) products in the US or ATMP products in Europe.
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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.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Experience in gene therapy drug development, RNA, nucleotide, and/or gene editing experience considered a plus. The Medical/Senior Medical Director will play a key role on cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted for the clinical development of our novel TRACER AAV capsid discovery platform programs in neurological diseases.
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The successful candidate must have a proven track record in the discovery and development of drugs targeting diseases of non-CNS/peripheral tissues, including liver, at least through IND, with more than one modality including biologics, small molecules, nucleic acid-based, or gene therapy products; and possess a solid understanding of FDA/EMA guidelines.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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You will be responsible for: Provide strategic vision and leadership in the research and development of optimal transgene expression cassettes to support the development of recombinant AAV vectors for gene therapy.
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Prepare formulations and perform characterization assays/data analysis with focus on in vivo studies, drug carrier design/development, assay development etc. is preferred " Gene Therapy and or proficiency in the above.
$47 an hourExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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You will be part of a team focused on performing and evaluating preclinical-stage studies that are critical in supporting our next-generation gene therapy research and development.
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Gene Therapy and or proficiency in the above. Support vaccine formulation development activities. We are seeking a highly motivated and scientifically rigorous individual to join the Delivery and formulation development team.
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You will play a key role in the design and oversight of nonclinical studies in discovery stages and in early preclinical development of gene therapy product candidates for inner ear disorders.
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Experience of working with multiple modalities ideally small molecules, ASOs, gene therapy, cell therapy and biologics. Is ultimately accountable for study protocol reviews to support DMPK Project TeamRepresentatives in experimental design and data interpretation.
$322,300 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Experience in an array of molecules including biologics, small molecules and gene therapy. Lead the Clinical Pharmacology team accountability for the clinical pharmacology strategy for Amylyx' development portfolio from pre-IND to approval, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions.
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Experienced with the drug approval process and the bioanalytical clinical development of nucleic acid (siRNA, ASO, mRNA, gene therapy), biologic, or small molecule drugs. This individual will be responsible for managing outsourced efforts to design and implement fit-for-purpose methods across various platform technologies, as well as the subsequent use of these assays for nonclinical or clinical bioanalytical sample analysis to inform on target engagement, downstream pharmacodynamics (PD), pharmacokinetics (PK), mechanism of action, and safety, to advance RNAi therapeutic development.
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