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Advanced knowledge of FDA guidance for industry for Analytical Procedures and Methods Validation for Drugs and Biologics. Functions may include, but are not limited to: Managing QC needs for clients, developing timelines and schedules for QC needs for complex projects, communication with both internal and client facing customers, and managing change controls and revision of documents per ICH guidelines for Biopharmaceutical Drug Substance (such as product specifications, validation protocols and reports.
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Thorough understanding of bioanalytical and biomarker methodologies, GLP/GCLP requirements, ICH guidelines, and FDA guidance for bioanalytical assay validation and sample analysis. Apply fit-for-purpose biomarker validation approach complied with FDA and global regulatory guidance under bioanalytical setting and follow CMS/CLIA and ISO guidance for the biomarker assays in clinical testing.
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Experience running programs that included assay development and validation. Experience with ISO and FDA quality systems regulations and medical design and development cycles. Hologic is seeking a Sr. Manager, PMO who will be dedicated to program management of new assay development and instrumentation/engineering project and programs.
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Assay Development: Focus on feasibility, verification and validation of new assays for commercialization. Ensures compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies.
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Compile and review CMC regulatory documents, including but not limited to Development Reports, Validation Protocols and Reports, NDA supplements, IND and NDA Annual Reports, and Responses to FDA information requests.
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Experience with the development, qualification, and validation of standard analytical tests for viral vaccines (e.g., virus infectivity, qPCR, RT-PCR, SDS-PAGE, western blots, sequencing, Next Generation Sequencing, ELISA) for Late-Stage development is highly preferred.
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Requires hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries and basic knowledge of refrigerator and freezer operation and temperature distribution patterns in storage spaces.
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Assist in the planning and designing of analytical and clinical validation studies, as well as post-market studies, to support U.S. FDA, CLIA, and ex-U.S. regulatory requirements. Prepare and manage regulatory submissions (e.g., pre-submissions, IDE, PMA, Technical Files, and other regulatory documentation) for product approvals required by the U.S. FDA and ex-U.S. regulatory bodies.
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ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
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Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy. Responsibilities: looking for a pure validation resource with periodic review, audit experience.
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2+ years' experience in pharmaceutical industry with microbiological testing such as sterility/bioburden, new product validation, LAL testing and validation, microbial identification, gram staining, purified water testing as per USP, bacteriostasis and growth promotion assay.
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Within the Analytical Developm ent department will participate in activities of development, tech transfer, optimization, qualification, and validation of analytical methods to support client product cell therapy manufacturing activities.
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As a Validation Specialist I, you will be responsible for generating System Development Life Cycle (SDLC) documentation and validating/qualifying systems used in the development and manufacturing of pharmaceutical products.
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This role is also responsible for submission readiness of study data packages per CDISC standards and FDA guidance, and enhancements of the statistical programming infrastructure of the Biometrics department as applicable.
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The Director, Research Consulting leads a team of researchers to conduct distributed network safety monitoring studies, clinical outcomes validation studies using charts, recruitment for pragmatic trials, as well as clinical program evaluation studies.
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