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The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
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Support cGMP manufacturing and technology transfer to our internal manufacturing facilities and external contract manufacturers. Advance enabling technologies to accelerate pharmaceutical development and to improve sustainability and process efficiency, including advances in biocatalysis, high-throughput technology, flow chemistry, and AI/machine learning.
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Doctorate degree in organic chemistry or biochemistry with a specialization in biocatalysis, oligonucleotide chemistry, 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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Support cGMP manufacturing and technology transfer to large-scale peptide production facilities. The Senior Principal Scientist role will include leading a multidisciplinary team of chemists and chemical engineers in the development of efficient and sustainable manufacturing processes for peptide synthesis and purification, driving technology innovation in the areas of chemical and microbial recombinant peptide production technologies, and providing technical expertise as well as developing and mentoring staff within the organization.
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Proven experience in radiopharmaceuticals manufacturing processes start-up, technology transfer, and validation. Experienced in critical regulations (occupational health & safety, radiation safety, devices, and quality standards (cGMP, Eudralex, ICH.
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The External Manufacturing Operations Senior Manager is responsible for driving technology transfer projects to completion within the GMP cell processing operations team and for ongoing manufacturing operations during the clinical phase of production.
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Lead the CMO selection process in collaboration with internal stakeholders to ensure alignment with the long-term clinical and commercial manufacturing strategies across all nodes of the supply chain; includes developing and negotiating development, technology transfer, and manufacturing/supply contracts.
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They will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical and Process Development Technology Transfer counterparts.
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This mission critical role will involve reagent optimization and preparation, including assay execution to support product development, as well as additional quality, regulatory and operational support for verification, validation, and technology transfer.
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Lead and manage multiple concurrent CMC Drug Product projects at CDMOs, including formulation development, process optimization and validation, cGMP manufacturing campaigns, and scale-ups and technology transfer.
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The newly created function will lead the technical oversight of the manufacturing network (in-house and outsourced production from a processes and technologies standpoint), manage the development life cycle, and deploy the automation technology to support the scale-up activities.
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Oversee process development and technology transfer activities. Expertise in cGMP regulations and biologics manufacturing processes. Manage all aspects of production, ensuring compliance with cGMP regulations.
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Job Overview: Seeking a Manager/Senior Manager CMC to oversee the outsourced process development and cGMP manufacturing campaigns for Drug Product of small molecule drug development programs. Possess a minimum of 5 years experience in the pharmaceutical industry, with a focus on formulation, process development, and cGMP manufacturing of solid oral dosage drug product.
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Sound knowledge of cGMP practices as applicable to process development, scale up, technology transfer, formulation development, and Manufacturing. You will provide expertise for the scale-up, tech transfer, and validation of upstream cell culture and viral vector unit operations in support of clinical/commercial manufacturing.
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Provide expertise for the scale up, tech transfer, and validation, of upstream cell culture and viral vector unit operations to internal and external partners in support of clinical/commercial manufacturing of.
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technology transfer cgmp jobs in Cambridge, MA
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