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This role also involves process scale-up and technology transfer of manufacturing related workflows to Contract Development and Manufacturing Organizations (CDMOs) or Regeneron based manufacturing suites to ensure timely and reliable entrance to the clinic through product commercialization.
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D. in pharmaceutical sciences or Engineering discipline with 3-5 years, or M.S. with 4-6 years experience in pharmaceutical industry with hands-on formulation/process development, and technology transfer to support LNP and other drug product manufacture.
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The successful candidate w ill have strong technical, scientific, management and leadership skills, experience in early process development through commercialization of biologics, process and analytical technology transfer, project management and the ability to influence across functions.
$155,000 - $214,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Interface internally and cross-functionally with Analytical Development, MSAT, Quality, Manufacturing, BD, Product, and Engineering to implement new processes and technologies as part of the core technology transfer team.
$90,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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New England Biolabs (NEB) is seeking a talented Process Development Scientist (Upstream). Preparation of upstream technology transfer documents (SOPs, batch records, etc. Experience with development scale fermentation equipment.
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The MS&T team is composed of scientists and engineers that conduct process development and optimization, scaled research vector manufacturing and technology transfer to GMP. To support the enormous growth of GTP, the MS&T team will be adding functional units that will conduct GMP manufacturing activities in a dedicated GMP space using GTP's platform manufacturing technologies.
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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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SAIC is seeking an Acquisition Security Specialist to support the Office of the Deputy Under Secretary of the Navy for Intelligence and Security, or DUSN (I&S), 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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Provide scientific, regulatory, and compliance oversight to the Biologics Analytical Technologies group responsible for analytical methods developed, optimized and performed to support preclinical, phase I through phase III clinical trials including raw material testing; in process, characterization and release bulk drug substance testing; and stability study testing for BDS and DP. Also, supports Phase III/licensure by technology transfer to external partners.
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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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Essential Functions Provide scientific, regulatory, and compliance oversight to the Biologics Analytical Technologies group responsible for analytical methods developed, optimized and performed to support preclinical, phase I through phase III clinical trials including raw material testing; in process, characterization and release bulk drug substance testing; and stability study testing for BDS and DP. Also, supports Phase III/licensure by technology transfer to external partners.
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Conduct ePMR/HAMR HDD products media process development and the technology transfer to offshore operation. Lead ePMR/HAMR media projects for evaluation of the media design process robustness and explore design tradeoffs; reach decision and meet the product development schedules.
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Play a pivotal role in technology transfer activities, leveraging expertise in cell culture processes to contribute to process enhancement initiatives. Facilitate the training and development of junior team members, actively participating in the formulation of standard operating procedures (SOPs) pertaining to cell culture manufacturing.
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6+ years’ experience in pharmaceutical manufacturing, process, or analytical development. - Support technology transfer to QC, assisting in method qualification and validation.
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Collaborating closely with the internal process chemistry team, manage API process technology transfer to the Company’s CDMOs, including process validation and the establishment and refinement of suitable specifications for APIs.
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