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The Product Development (PD) Senior Scientist I, under minimal guidance, designs, plans and conducts pre-formulation, formulation and process development activities as well as scale-up trials of complex projects using risk-based approach.
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The North America organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Strong command of the drug development process, regulatory environment, and legal and compliance regulations governing Medical Affairs activities is required.
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The CMO works closely with the Research and Development organizations driving overarching scientific leadership specifically in Hematology/Oncology, Bone Mineral, Rare Disease and Gene & Cell therapies, and in future therapeutic areas that may arise.
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PhD in Pharmaceutical Science or a related scientific field with at least 7 years of experience in pharmaceutical formulation and product development. Bachelor's degree in Pharmaceutical Science or a related scientific field with at least 15 years of experience in pharmaceutical formulation and product development.
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Designs, plans and conducts product development activities, including pre-formulation, formulation, process development and scale up studies of complex projects to ensure good scientific standards are met.
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It offers services in the areas of custom synthesis/contract research, process and analytical research, cGMP synthesis, crystallization process development, solid form screening and selection, pre/early formulation, and drug substance-drug product coprocessing.
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The candidate should possess the ability to pursue complex technical issues and innovative solutions in the areas of product, packages, process, mechanistic understanding and consumer insights.
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Technical expertise includes Column Chromatography, tangential flow filtration, cGMP compliance, SOP development, operational/workflow efficiency, process validation and technology transfers.
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Experience in Sterile drug product process development, Microbiology, Facility Engineering, Manufacturing, Supply Chain, Validation, and EHS Experience in the application of state-of-the-art laboratory equipment and software.
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Knowledge of the drug development and clinical trial process, including the Product Development and Commercialization Process preferred. Driving progress and optimal execution of clinical development and data generation plans aligned to tumor strategies through the PD&C process.
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We are adept in synthetic chemistry and process research services, which include Process Chemistry, Quality Control, Good Manufacturing Practice, Quality Assurance, Crystallization Research and Development, Solid Form and Polymorph Screening, Catalysis Screening and Enabling Technology, High Potent Compound Handling (HPAPI), Impurity Isolation and Structural Elucidation, and Preformulation and Formulation Research and Development.
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From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved.
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Collaborates with Integra's Quality, Supply Chain, Regulatory, Operations and Product Development teams to achieve process, technology, operations, and quality objectives in addition to performance goals for the contract manufacturer(s) or business partnerships.
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Should have good understanding of both Agile (SCRUM) and Waterfall delivery principles and the importance of SDLC (Software Development Process) and coding methodology principles. Must have strong CPQ and Billing experience including Amendments and Cancellations, Product Rules, Pricing Rules, CPQ Pricing Scripts, Advanced Approvals, Vertex Integration, Credit Notes, Debit Notes, and Payments.
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Provide support to business development, customer success and delivery teams for FinTech related offerings; discuss and advise customers and prospects on flow of funds, back-office process, user experience, etc.
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process development product jobs in Princeton, NJ
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