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Responsibilities Support the development of the Drug Substance strategy and oversee manufacturing of preclinical and clinical material. Senior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team.
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Experience in development of purification strategies using various chromatographic techniques such as affinity, size exclusion, ion-exchange, hydrophobic interaction, and tangential flow filtration (TFF)Experience in analytical characterization of ADCs including SEC, RP-HPLC, LC-MS, CE-SDS, ELISA, DSC, and HICExperience with biological assays such as measuring cytotoxic activity for ADC characterization.
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This position offers a unique opportunity to work in a dynamic and innovative environment developing your career at the interface of mechanistic research, drug discovery, and preclinical drug development.
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Minimum 12 years' experience as a safety physician with the biotechnology / pharmaceutical industry, leading drug safety & pharmacovigilance, including cross-functional team leadership for signal detection, evaluation, risk classification and management, and communication, for products across multiple stages of development.
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We are seeking a Director, Pharmacovigilance and Drug Safety (Operations & Compliance) to join our team. Provides oversight of case processing activities for the Xenon clinical development program and serves as safety data management subject matter expert (SME) on regulations and best practices for conventions and handling of safety data in Xenon’s global safety database (GSDB.
$210,000 - $239,500 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Collaborate with CRO and academic partners; employ cutting-edge in vitro and in vivo animal and human models to advance drug discovery and development programs up to and including IND filing.
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You will also work with the internal drug development team as well as collaborators to deploy Manifold's proprietary protein barcoding technology for in vitro and in vivo drug development efforts.
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Deliver impactful outcomes by leveraging a deep understanding and experience in navigating typical workflows within drug discovery, drug development, gene-to-antibody, and proteomics.
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Affini-T Therapeutics is announcing a Senior Director, Head of Product Sciences opportunity at our headquarters in Watertown, MA. Position Summary The Head of Product Sciences role is situated within the larger CMC organization responsible for process development, analytical development, technology transfers, manufacturing, and supply of our drug product TCR T cell candidates, drug substance and critical intermediates such as gene editing reagents, viral (LVV) and non-viral vectors.
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Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products.
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The in vivo Gene Editing and Critical Components Process Development team in the Technical Development Department is seeking a highly motivated Process Engineer for the process and formulation development of critical gene editing components and drug products [e.g. Ribonucleoprotein (RNP), messenger RNA (mRNA) & Lipid Nanoparticle (LNP.
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LifeCanvas offers cutting-edge technologies and end-to-end solutions that enable holistic molecular imaging of biological systems to accelerate the pace of breakthrough discoveries in science and the development of new therapeutic strategies.
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Manage developing, validating, and standardizing complex GC, GC/MS, HPLC, LC/MS, ICP/MS analytical methods for isolation, detection, identification, and quantification of both drug substances and drug products of small molecules or/and large molecules.
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Our products are used for drug research and assay development. In addition to protein crystallography automated microscopy imagers, we also provide automated liquid handlers. Experience with robotics, software, microfluidics, and optics are a plus.
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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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drug development jobs in Boston, MA
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