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Powder characterization scientist will be responsible for characterization of particle and powder properties to guide robust drug substance and drug product development throughout all stages of development (from discovery to commercialization.
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Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China. Lead drug product development activities to advance new chemical entities (NCE) from the preclinical lead optimization stage through commercialization.
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Playing a critical role as the drug product technical lead and CMC project lead, this position will be responsible for drug product development activities leading to NDA submission and commercialization and development and execution of the CMC strategy.
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Frontage Laboratories is a CRO/Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals.
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As a key member of our Drug Delivery Programs team, the successful Senior Product Development Engineer is responsible for providing mechanical design engineering technical leadership on cross-functional product development teams during the pre-concept, development, design, test and documentation for manufacture of new and improved disposable medical and surgical devices, instruments or related products.
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Contribute as part of the Bioassay development team towards the development and execution of various cell-based analytical methods to support drug product characterization, release, and stability.
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Background encompasses manufacturing process development of parenteral drug product, including oligos, protein, peptide, viral or cell therapeutics. Extensive experience in parenteral drug product process development.
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Represent Drug Product team in CM&C teams and support the formulation and process development of protein, peptide, oligonucleotides and other novel modalities in clinical development.
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The candidate will be responsible for formulation and process development activities of oligonucleotide drug product programs to support Biogen’s growing pipeline. Biogen is presently looking to fill a Scientist II position within its Anti-Sense Oligonucleotide (ASO) Formulation and Drug Product Development group.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The Senior Principal Scientist will collaborate across BMS sites with Analytical, Drug Product, Drug Substance, Quality, and Regulatory leads to execute drug product formulation/process development support, analytical strategies for drug product methods and specifications, analytical control strategies, and support of product development up to drug application submissions and approval.
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Collaborate with marketing, sales, and product development teams to align industry relationship strategies with overall business goals. Simpson Strong-Tie's drug policy is based upon Federal Law, and therefore will screen applicants for amphetamines, including methamphetamines, cocaine, phencyclidine, opiates, and marijuana.
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The successful candidate should have strong expertise in immuno-oncology and will be focused on focus on the development of fit-for-purpose CMC assays using flow cytometry and cell-based immunoassays, to characterize engineered TCR-T cell drug substance and drug product.
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Development and on-site support of cGMP drug product manufacturing processes. Execution of formulation and process development study protocols, stability and product characterization studies.
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Quality Control Specialist-Large Molecule Exton, PA (Corporate) Frontage Laboratories Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals.
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Engineering Director (Scientific) – Drug Product Development. The drug product team is also investing in building new platforms to support complex formulations such as lipid nanoparticles, Antibody Drug Conjugates and AAV and other non-viral vector delivery.
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