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Technical lead of analytical method development for nucleic acids, lipids, & lipid nanoparticles as part of development of FL85 platform, product, process, and formulations. Serve as analytical lead on product development and/or platform teams.
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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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Job DescriptionPerform and analyze experiments to generate purification process development, formulation or a drug product process steps to support production of biologic therapeutics such as monoclonal antibodies, adeno-associated viruses, or oligonucleotides with significant guidance from supervisor.
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PhD in Analytical Chemistry with 6+ years in CMC analytical development for small molecule Drug Substance and Drug Product. Job Overview: The Principal Scientist in Analytical Development guides pharmaceutical advancements from inception through clinical stages and collaborates with internal and external partners.
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TheHead of Product Development and RegCMC, Biologics and Advanced Therapy Medicinal Productsleadership role in PO&T is responsible for the process, analytical, and technology development of all biologic and advanced therapy medicinal product (ATMP) modalities including existing protein-based drugs, monoclonal antibodies, and gene therapy assets.
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Represent HEOR / Market Access function with Alliance (Co-Development) partners (e.g. sitting on Alliance cross-functional Global Product Teams, market access sub-teams, etc). Role model and cultivate a culture of teamwork and coordinate with cross-functional team to ensure that patient-relevant and reimbursement-relevant endpoints are incorporated into clinical stages of product development to facilitate Sarepta development programs.
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We are a full-stack shop consisting of product and portfolio leadership, data engineering, infrastructure and DevOps, data / metadata / knowledge platforms, and AI/ML and analysis platforms, all geared toward:Building a next-generation data experience for GSK’s scientists, engineers, and decision-makers, increasing productivity, and reducing time spent on “data mechanics.
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You will be a member of the Kensho's strategy organization, reporting to the Head of Strategic Initiatives and Partnerships and working closely with the Head of Operations, as well as a cross-functional team consisting of business development, product, legal, communications, design, and engineering roles at Kensho and S&P Global divisions (Commodity Insights, Market Intelligence, Ratings, Indices, and Mobility.
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As an integral member of the team that will be tasked with product development, the Associate Director Regulatory Affairs will also serve as a subject matter expert (SME) for assigned development programs, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements.
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Represent GMAx SPC in key decision-making forums: Specialty Care Leadership Team, TARC (Therapeutic Area Committee), PSC (Product Strategy Committee), Specialty Care Strategy Days, Tender Board, Restricted Tender Management Board, ad hoc IDCC (Integrated Development & Commercial Council.
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Performing high-sample volume testing by Liquid Chromatography (LC), Capillary Electrophoresis (CE), and wet chemistry methods in support of Drug Substance, Drug Product, and Attribute Sciences process development teams.
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Responsibility may extend from early translational development activities to mature product life cycle strategies and back translational activities Manage the design, conduct, interpretation, and reporting of biomarker data/activities in line with the development, regulatory, and commercial strategies Lead asset-specific translational projects/teams in a matrix environment.
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Provide QA oversight of method development, qualification, tech transfer, and validation for Drug Substance and Drug Product conducted at external labs and vendors. Influence the overall CMC development strategy throughout the product lifecycle based on current industry standards and health authority guidance.
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Product development: work closely with Data science and Product to derive and prioritize customer needs into the product roadmap and continuously improving the fit to evolving market needs.
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The Clinical Research Director (CRD), Dupilumab, Immunology and Inflammation Therapeutic Area is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy.
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product development jobs in Cambridge, Wailuku, Hawaii
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