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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 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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The successful candidate will lead and oversee formulation-drug product process development, tech transfer, and manufacturing with external development and manufacturing partners; in addition to leveraging Cerevel's internal formulation development capabilities as well as a growing array of analytical and physical characterization instruments.
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Contribute to the development of a healthy product backlog, collaborating with the Product Manager, Engineering, and Solution Architects to break down business epics, document user stories (to also include things like addressing technical debt, SRE, etc.
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Apply advanced knowledge of FDA and CAP/CLIA regulations, genomics, DNA sequencing and molecular biology products and services for marketing/product management including market analysis, planning and new product development.
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Collaborate with cross-functional teams including members from assay development, software engineering, marketing, quality, regulatory, and others to execute complex product development projects.
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Content Development: Hands-on leadership of the creation of high-impact content, including white papers, blog posts, case studies, and product datasheets that resonate with our target audience and drive lead generation.
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Our solutions span use cases across the product life cycle, from product development to mass production and aftermarket operations, and they address an array of industries, including automotive, aerospace, healthcare, consumer products, heavy industry, machine design and research and development.
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Ability to work in cross-functional project teams that are focused on the commercialization of a given product that includes the development and technology transfer of processes from laboratory scale to pilot and manufacturing scale.
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This role will be key in supporting vaccine tech transfer and process development. Sound knowledge of cGMP practices as applicable to process development, scale up, technology transfer, formulation development, and Manufacturing.
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Lead right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream processing, downstream processing, aseptic fill finish and final product visual inspection.
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Cross-functional Collaboration : Work closely with backend developers, product managers, designers, and other stakeholders to ensure that the frontend development aligns with the overall product strategy and meets user needs.
$80,000 - $90,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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You're the right fit if: You’ve acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K’s, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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Technical Client Solutions/Business Integration/Product Development, AVP - HybridWho we are looking forWe are seeking a Product Development Assistant Vice President to design, build and implement solutions for clients internally and externally.
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Serve as subject matter expert in collaborative development and tech transfer of analytical methods between internal stakeholders and external AD and QC organizations. Support the development and routine execution of analytical methods to release and characterize Kelonia’s injectable gene therapy products.
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product development jobs Company: Mufg in Waltham, MA
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