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Providing analytical support to Upstream and Downstream process development team activities by ensuring consistent and timely execution of standardized platform product characterization assays, including data review, storage and trending.
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In this role, you will be responsible for analytical testing (cell and molecular biology assays) as well as excursion/deviation investigations and reports in support of ElevateBio's gene and cell therapy programs.
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Proven track record of leading successful in vitro pharmacology efforts in the field of Cell Therapy, including assay development and validation, candidate screening, and mechanism of action studies.
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Demonstrate basic knowledge of the GXP cellular therapy product manufacturing, and program development and evaluation, as well as needs assessment and marketing of the programWorking knowledge of flow cytometry, molecular biology, and genetic engineering is a plus.
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Vertex operates at the forefront of scientific innovation and has successfully developed and commercialized multiple breakthrough medicines for Cystic Fibrosis (CF) as well as Casgevy, a gene therapy for sickle cell disease and beta-thalassemia.
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Proven experience working with complex matrices and cell isolation, ideally also exposure to technologies required for cell and gene therapy products such as NGS, PCR variations including ddPCR, flow cytometry.
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The candidate will perform literature search about the newest trend and technology in Cell and Gene Therapy development, majorly focused on finding a way to make stable inducible host cells line to product viral vectors.
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As the Associate Director of Strategic Sourcing for Cell and Gene Therapy (CGT) Raw Materials, you will be a part of a fast-growing and innovative organization at the company's world headquarters in Boston, MA. The department is committed to a trusting and collaborative culture where we value growth and development.
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You will be working with the Cell Therapy Process Development team and will be a qualified DD&T leader to drive CMC digitalization technologies and endpoints across Takeda pipeline and platform activities.
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With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy, and Epigenetics) to help address unmet clinical needs in a host of cancers, we are motivated by a dedication to the scientific discovery and collaboration that will one day help eliminate cancer as a cause of death.
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Development, optimization, qualification, transfer, validation, and routine execution of analytical methods for proteins, mAbs, drug conjugates using techniques pertinent to LC (SEC, RP, IEX), LCMS, ELISA, CE-SDS, icIEF, and other wet chemistry techniques.
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Experience with Preclinical to Phase 2 stage product development with Gene and Cell Therapy products. Founded and guided by leaders drawn from the top of the cell and gene therapy field, we feel an urgency and passion for our work driven by its potential global impact.
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You will be working alongside lab SME, Data Engineering, and the Emerging Technologies team to help digitize our process development, analytical development, and manufacturing workflows and enable cross-functional access to data.
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Oversee CDMOs for phase-appropriate analytical method development, qualification, validation, and transfer for in-process testing, drug substance (DS) and drug product (DP) release and stability testing.
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The successful candidate needs to demonstrate hands-on novel analytical development skills and a proven track record of managing CROs and CDMOs∯*∯ Experience with long acting injectable product development is a plus.
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product development analytical cell therapy jobs Title: director in Cambridge, MA
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