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Charter cross functional tech transfer teams comprising of R&D, QA, QC, Regulatory Affairs, and operations. Responsible for developing biologics process control strategy document, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D and ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation.
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Responsible for all aspects of product design including - systems architecture, electrical engineering design, component selection, embedded systems / microprocessor based design and programing, requirements documentation, design verification, design validation, regulatory compliance, test plan creation, test tools and test scripts development, DFM/DFT, design reviews, and DFMEA. Lead projects ranging from short-term technology investigations to full-scale product development.
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Qualified candidates must currently be enrolled in an accredited undergraduate program with a concentration in Chemical, Biochemical, Biomedical or other related Engineering disciplines, Regulatory or pharmaceutical science, or other related fields in science and technology (Chemistry, Biology, Microbiology, Operations Research, Industrial Engineering, etc.
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Strong knowledge of FDA, cGMPs, and ICH guidelines and QBD principles pertaining to analytical development, method validation, technology transfer and quality control testing. Coordination with internal and external stakeholders, including Process Development, External Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, Clinical Supply, Clinical Operations, and Program management.
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Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation. Our team looks forward to welcoming an experienced Bioprocess Engineer with a strong background in the regulated (bio)pharmaceutical environment supporting laboratory, pilot and commercial scale process development, mRNA technology transfer to internal and external GMP production facilities and commercial production of mRNA therapies.
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Co-Own the site tech transfer process and SOP with R&D. Charter cross functional tech transfer teams comprising of R&D, QA, QC, Regulatory Affairs, and operations. Accountable for product life cycle technology transfer, engineering, clinical, exhibit, PPQ/process validation, and control strategy development.
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Collaboration with other functions across the company to achieve maximum success, including analytical R&D, process development, application technology, biology, agronomy, regulatory, operations, and commercial teams.
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Establish and maintain partnerships with internal teams and external organizations supporting development, technology transfer, process validation, and commercialization of drug products.
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Collaboration with other functions across the company to deliver maximum success, such as analytical R&D, process development, application technology, biology, agronomy, regulatory, operations and commercial teams.
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Provide strategic thought leadership in collaborating with Roche's SAP Serialization Enterprise Team to architect, design, build and test a custom solution that integrates with Client's existing SAP Serialization Enterprise Solution meeting Client's Manufacturing, Contract Manufacturing Organization, Product Distribution Center, and regulatory business requirements.
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This position plays a leading role of purification group in technology transfer, troubleshooting processes, building a detailed understanding of them, and driving process robustness by setting clear objectives and empowering their team.
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The AVP RSP oversees all University policies and procedures relating to research, including external grant and contract proposal development, grant and contract administration, research and regulatory compliance, internal research award programs, intellectual property issues, technology transfer, and economic development.
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SAIC is seeking a Counterintelligence Analyst to support the Naval Criminal Investigative Service (NCIS) as part of a cross-functional Department of Navy (DON) team charged with developing, implementing, and overseeing the Small Business Innovation Research (SBIR) / Small Business Technology Transfer (STTR) Due Diligence process.
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Knowledgeable in process and analytical development, phase appropriate technology transfer, process comparability and qualification, CMC regulatory guidelines, process monitoring and analytics, manufacturing operations support, and GMPs, ICH, ISPE, and BPE guidelines.
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Facilitate technology transfer into the internal late stage clinical and commercial manufacturing facility and at CMOs. This leader and the team will need to coordinate cross-functionally with Process and Analytical Development, Internal and External Manufacturing, Validation and Metrology, Quality Control and Analytical Technologies (QCAT), Quality Assurance, and Regulatory to support process validation and manufacturing of gene editing components and ex vivo CRISPR gene-edited cell therapies both internally and at Contract Manufacturing Organizations (CMOs.
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