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Company is currently seeking an Analytical Chemist in our Pivotal Attribute Sciences Department in Cambridge, MA. This team plays a crucial role in pivotal phase analytical support, including product development support, testing of drug substances and drug products.
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Familiarity with process biology principles and their integration into cell therapy product development, including scalability and manufacturability is required. Experience in preclinical assay development, immune cell functionality testing, and validation in the context of cell therapy.
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You will define and execute process development and tech transfer activities to enable iPSC expansion and differentiation in GMP manufacturing throughout the product lifecycle. The Director, Process Development will be responsible for leading and empowering the Process Development Team for process development, formulation development, process scale-up, optimization, and technical transfer of the Company’s product candidates.
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Experience in CRO management, biomarker assay qualification/validation, and familiarity with assay development under a regulated environment (CAP/CLIA, GCP/GCLP, IVDR or equivalent) is preferred.
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PK Science is an enterprise organization, working across both Biomedical Research (BR) and the Global Drug Development (D) organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology from discovery through approval and life-cycle management.
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression.
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Contribute to the development of a healthy product backlog, collaborating with the Product Manager, Engineering, and Solution Architects to break down business epics, document user stories (to also include things like addressing technical debt, SRE, etc.
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Work closely with the NPP Medical Director, and cross functionally with US Medical Unit team members, US Business Unit NPP, Market Access and Channel function, and franchise marketing/brand teams to facilitate in-depth scientific HEOR knowledge, product value, and strategy development.
$266,200 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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.
$198,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Lead the analytical team to provide support for studies including solubility, pre-formulation, control, intermediate stability, starting material, drug substance and drug product in all stage of development.
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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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Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, edit check specifications, and data management plans identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF.
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The QA Automation analyst requires extensive knowledge of tools such as Selenium, Cypress, Jest for front-end testing, Playwright for UI testing and Postman or SoapUI for APIs. In addition, you will have experience with CI/CD processes, Agile development, and version control systems such as Git. This role directly reports to the Software Development Manager.
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Collaborate with cross-functional teams to integrate findings into the broader oncology research and development strategy Document, analyze, and interpret experimental results promptly to guide project strategy and next steps.
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Contribute to the visual merchandising efforts by zoning product displays, ensuring proper signage, and maintaining a clean, safe, and attractive sales floor during periods when not assisting customers.
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product development jobs Title: analytical chemist in Cambridge, TN, Us
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