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Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.
$221,170 - $286,220 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The VP of Drug Safety and Pharmacovigilance will provide the leadership and management for the infrastructure of the Drug Safety and Pharmacovigilance department across both clinical development and commercial products for the company.
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Proven experience in the integration and management of PDM, and PLM systems for the product development life cycle within a manufacturing or engineering environment. , ECO process, product structure, configuration engineering, change management, and revision control and tracking.
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We're seeking a Business Development leader in biotech or pharma to play a leadership role in developing and executing our business strategy of Twist Antibody Drug discovery capabilities and expanding our growth and value creation opportunities including partnerships, alliances, out-licensing deals and other collaborations.
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Key responsibilities of the Analytical Development Associate Scientist are summarized below, and these will evolve over time as the portfolio matures. Prior experience in cell therapy, biotechnology industry, analytical development preferred.
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In this vital role you will be responsible for the development and implementation of the Quantitative Clinical Pharmacology, Modeling and Simulation strategies for cutting-edge novel modalities including Bi-specific T-cell engagers, Bi-specific antibodies, oncolytic viruses, antibody-drug-conjugates, CAR-T cells-based therapies in addition to small molecule & mono-clonal antibodies.
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5+ years of post-PhD experience in biotech industry, ideally in gene therapy or related next-generation drug development field such as biologics. Experience with clinical biostatistics, clinical trial development and/or regulatory filings in the context of therapeutic drug development.
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Reports to: Associate Director, Analytical Development. Extensive expertise in U/HPLC, CE, SDS-PAGE, mass spectrometry, and other analytical technologies as applied to protein analytical method development, trouble shooting and validation for GMP release and stability testing.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Job Description POSITION SUMMARY The Director, Project Management is responsible for managing cross-functional drug development projects, in either preclinical or clinical development stages.
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Planning and execution of mechanistic PKPD analyses to integrate knowledge of drug design parameters, disease pharmacology, physiology, pharmacokinetics and pharmacodynamics, and to optimize selection doses and preclinical study designs.
$191,600 - $236,280 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Out client is looking for a highly skilled, motivated, and creative analytical scientist to join their Vaccine Product Development organization as Scientist I within Protein Development and Clinical Manufacturing.
$150ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Program Development:Contribute to the development and implementation of case management programs and initiatives. Certified Case Manager (CCM), Certified Alcohol and Drug Counselor (CADC), or Mental Health First Aid.
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Associate Director, Analytical Development, Raw Materials. Vaxcyte is looking for an energetic and talented individual to join our analytical development team. Independently perform method development across a broad range of analytical methods for raw materials for QC and characterization purpose to support pre-clinical and clinical projects.
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Broad hands-on experience with modern analytical instrumentations commonly used in the analysis and characterization of biologics, carbohydrates, conjugates and small molecule drug candidates and successful track record of method development trouble shooting and validation, e.g., UV-Vis, various modes of HPLC, CE, SDS-PAGE, icIEF, LCMS, GCMS, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, etc.
$150Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Candidates with B.S./M.S. may also be considered with demonstrated leadership track record in analytical development and drug product process development. ● Define analytical testing strategies of raw materials, biological starting materials, in-process samples, impurity quantitation, and drug product release and stability, including selection and development of fit-for-purpose methods.
$200ExpandApply NowActive JobUpdated Today
product development management drug jobs Title: development director Company: Omeros in San Mateo, CA
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