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Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China. 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.
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Experience in oncology drug development. Extensive training and experience in the design and conduct of in vitro and in vivo preclinical pharmacology and toxicology studies directed at the development of pharmaceuticals or biologics.
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The Senior Manager/Associate Director, Drug Substance Development and Manufacturing will oversee key scientific, regulatory, and business functions pertaining to process chemistry for the organization.
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Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II - IV Clinical Research services.
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The Associate Director, Drug Product Process Development, reporting to DP Technologies (DPT) in Global Biopharmaceutical Development (GBD), is a critical role in our development team and will help lead the successful development and commercialization of biologics product candidates.
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Represent Drug Product team in CM&C teams and support the formulation and process development of protein, peptide, oligonucleotides and other novel modalities in clinical development.
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Strong understanding of science and drug development, with specific expertise in nonclinical study design, preclinical CROs, data management systems, nonclinical study procedures, and statistical analysis methods.
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The candidate will also teach in other programs in the School of Pharmacy including the MS degree program in Artificial Intelligence and Computational Drug Discovery and Development, the PhD program in Pharmaceutical Sciences and Pharmacogenomics and the PharmD program.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modeling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Abbvie is seeking a highly motivated and experienced translational scientist to lead a team of senior scientists accountable for driving the development, planning, and execution of the clinical translational research and precision medicine strategy across the rheumatology drug pipeline at Abbvie.
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Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
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The Associate Director/ Director will also have the opportunity to cross-sell the wide variety of services offered by Frontage that are applicable to drug discovery, pre-clinical development, and clinical trials which will include Clinical, Central Lab, DMPK, CMC, and a wide variety of bioanalytical, biomarker, and biologic services offered within the Frontage Bioanalytical business unit.
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We are seeking a Director, Pharmacovigilance and Drug Safety (Operations & Compliance) to join our team. Provides oversight of case processing activities for the Xenon clinical development program and serves as safety data management subject matter expert (SME) on regulations and best practices for conventions and handling of safety data in Xenon’s global safety database (GSDB.
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The Director of Bioconjugation at Abzena Bristol site will be responsible for managing key client account programs, and overseeing key research, development and production operations related to antibody-drug conjugates, conjugated vaccines, oligonucleotide-protein conjugates, and other conjugated products.
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Proven track record of drug discovery, development and manufacture with extensive CMC and GLP/GMP knowledge and experiences. Coordinate activities with QA/QC and Management for development of tox and GLP batches.
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drug development jobs Title: director in Crossville, Tennessee
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