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10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs / small molecules.
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Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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We are seeking a creative, experienced, and motivated Associate Scientist to join our growing CMC Process Development team. Evaluate and define critical quality attributes of drug substances and drug products to aid in process and formulation development.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The Toxicologist works in a team environment (toxicology, pharmacology, medical/clinical, regulatory, CMC) in Biotech drug discovery and development. The Toxicologist will work with external partners such as CROs to conduct the necessary studies to support drug development, and to monitor study progress.
Part-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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Act as the lead clinical pharmacologist on clinical pharmacology study teams to support clinical development: independently lead the design, protocol development, execution, analysis, and reporting of clinical pharmacology studies (e.g., food effect, BA/BE, human ADME, drug interactions, renal and hepatic impairment, etc.
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Experience in biopharmaceutics/drug absorption, related tools (in-vivo, in-vitro, in-silico), and product design and development. Familiarity with regulatory biopharmaceutics requirements and drug development processes.
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Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve patient lives. The successful candidate excels in a collaborative, cross-functional, matrix team environment to enable the development of new drug products for pharmaceutics, biologics, and emerging modalities such as, but not limited to, antibody-drug conjugates, gene therapy, oligonucleotides, and SiRNA nanoparticulate delivery.
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They will work closely with colleagues across Technical Operations, Global Product Quality, and Regulatory CMC as they drive the drug product development, validation, and commercial manufacture, and launch.
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Liaise and negotiate with global regulatory authorities as needed for all aspects related to drug development including resolution of key CMC regulatory issues and to expedite approvals of product.
$234,900 - $290,200 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Understanding of cell line development and CMC activities. RESPONSIBILITIES Reporting to the Director, Biotherapeutics the Senior Scientist will be part of the Biotherapeutics Drug Discovery team.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Provide technical and CMC regulatory support to external partners using the NTxscribe® and NTxpress® platforms for the manufacture of biologics drug substance for nonclinical and early phase clinical studies.
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Must possess a solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development. AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic biologic products.
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BMS’s internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and other therapeutic modalities.
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MD, PhD, DVM, PharmD, MBA or equivalent advanced degree of relevance, in the drug development process. Uses an understanding of disease biology, the drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area therapeutic advances, and evolving regulatory, patient advocacy and market access environments) to create a vision for each asset, then design and execute effective development programs in support of the overall R&D portfolio goals.
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