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Amgen is currently seeking a talented Process Development Senior Scientist to join our Drug Substance Technologies - Synthetics (DSTS) group at Cambridge, MA. Amgen's DSTS group within Process Development (PD) is responsible for the invention and development of drug substance manufacturing processes and technologies to advance Amgen's exciting portfolio of synthetic and hybrid assets.
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Provide analytical data to support drug substance and drug product development, including purity analysis, chiral purity and structure elucidation using mass spectrometry. Collaborate closely with drug substance and drug product process development colleagues to achieve project objectives.
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The Nucleic Acid Vaccines Center of Excellence (NAV CoE), a global team within the GSK’s Drugs Substance (DS) Vaccine’s Technical Research and Development organization, has as a mission to develop the next generation RNA Drug Substance vaccine platforms for rapid development of new vaccine candidates.
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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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Experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality. The Company DPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries.
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They develop new methods using chromatographic, characterization, and wet chemistry techniques to enable small molecule drug substance and drug product development throughout various stages of drug development.
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Primary Job Responsibilities:Manage CDMOs and vendors, ensuring collaboration and timely deliveryFocus on drug substance development, with preference for oligo experienceReview MBRs, EBRs, and IND Module 3 for compliance and accuracyPrimary Job Requirements:Bachelors degree with a minimum of 5 years of exp in CMC process development.
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As a CMC development lead, the individual will apply their strong expertise in CMC fermentation and/or purification to develop robust, phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure.
$200,000 - $240,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Lead drug substance team through preclinical and clinical development to commercialization across Astria’s pipeline. This role will oversee all drug substance process development for the company and will play a key role in driving the portfolio forward from early process development through late stage, including process characterization, validation, and commercialization.
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Experience in collaborating with process development, QC/AD and supply chain/logistics functions in assuring supply of necessary components to assure drug substance timelines are met.
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Responsible for all aspects drug substance including conjugation process development, validation, characterization, scale-up, tech transfer, analytical method qualification, specifications, release and stability testing.
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Develop and implement comprehensive strategies for early-stage formulation and process development for biologics, including characterization, pre-formulation, evaluation of multiple formulation options, process design and optimization, scale-up, and manufacturing of drug product under both non-GMP and cGMP.
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Collaborate cross-functionally with other departments including process engineering, tech transfer, drug substance, and analytical development. D. in pharmaceutical sciences or Engineering discipline with 3-5 years, or M.S. with 4-6 years experience in pharmaceutical industry with hands-on formulation/process development, and technology transfer to support LNP and other drug product manufacture.
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In addition, the successful candidate will oversee the selection, tech transfer and execution of drug substance development and manufacturing plans at external partners. PhD degree in chemistry, chemical engineering or related scientific field with 12+ years’ experience in drug substance development and manufacturing.
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Perform QC review/approval of analytical test data for IPC testing, drug substance/product batch release and stability test data. If you have been working in the lab environment for the past few years and want to grow in the latest trend of working in the virtual organization while still delving into the science of drug development, this is the role you are looking for.
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drug development substance jobs in Watertown, MA
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