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Lead pre-formulation, final form selection, formulation and process development, clinical manufacturing, scale-up, tech transfer, process optimization, and process validation activities related to solid oral dosage and parenteral drug products.
$108 - $118 an hourFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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In addition, the Manager Drug Product Development and Manufacturing will support all aspects of non-GMP and GMP drug product manufacturing and ensure that the CMC team is aligned with the manufacturing strategy at each CMO. A strong knowledge of sterile parenteral filling and the requirements of clinical supply manufacturing is required as well as a working knowledge of cGMP and FDA/EMA guidelines.
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Extensive knowledge of drug product manufacturing processes, especially assembly-labeling-packaging processes), characterization, tech transfer, and validation activities. In this role, you will lead and coordinate Packaging Process Validation, Packaging and Device Components Qualifications, upcoming Commercial Support, Process Monitoring, Deviations/CAPA’s and Close Collaboration with Drug Product Manufacturing and Combination Products Development team.
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The Head of Product Sciences role is situated within the larger CMC organization responsible for process development, analytical development, technology transfers, manufacturing, and supply of our drug product TCR T cell candidates, drug substance and critical intermediates such as gene editing reagents, viral (LVV) and non-viral vectors.
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Lead matrixed Drug Product teams to advance formulation development, fill/finish process development, process characterization, container development, packaging development, technology transfer, and regulatory authoring of our mRNA portfolio candidates in late-stage development.
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Downstream Bioprocess - Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance and drug product for clinical and commercial manufacture.
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Reporting directly to the Chief Operating Officer (COO), this role will be responsible for managing the scale-up and tech transfer of Antheia's products to manufacturing partners, working with R&D functions to develop product / process development plans and timelines.
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Experienced in tech transfer of a process from development to manufacturing or between manufacturing sites. Cellics Therapeutics is seeking a Principal Scientist/Associate Director, Upstream Process Development and Manufacturing to lead the execution of CMC strategies in cell culture process development and manufacturing in support of our drug development and regulatory filings.
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You will join the Drug Product Development team responsible for formulation and drug product process development, scale-up, and technology transfer for novel viral vectors being developed for in vivo gene therapy.
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The Associate Director of Analytical Development will play a key role in leading the development, validation, and transfer of analytical methods for ophthalmic drug delivery systems.
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The qualified individual will be responsible for the design, execution, and management of scientific studies in the development of both liquid and /or lyophilized drug product formulation to support product development from initial candidate identification through commercialization.
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This includes profiling of physicochemical properties, development of preclinical formulations, identifying solutions to in vivo absorption challenges, and advancement of novel drug delivery strategies across multiple routes of administration that are aligned with program target product profiles and downstream partners.
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Provide strategic direction and guidance to the formulation development team on all aspects of injectable small molecule, peptide, and protein formulations, including process development, characterization, scale-up, tech transfer and manufacturing support.
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The TeamAs part of IM’s Quantitative Research and Development group, the “Quantitative Product Management” team focuses on initiatives that improve or create new capabilities and tools for portfolio management and Asset Liability Management stakeholders.
$148,300 - $194,600Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Senior Scientist (Upstream Tech Transfer)Introduction to role:Join us in the Cell Culture and Fermentation Sciences (CCFS) department within Biopharmaceutical Development (BPD). Proactively addresses risks/issues to avoid non-conformances and enable efficient transfersServe as SME and provide technical support to manufacturing within AZ and external partnersSupport building the tech transfer roadmaps for accelerated development timelines, and novel biologic modalities.
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product development management drug tech transfer jobs Title: development director
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