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The Senior Director, Drug Safety & Pharmacovigilance will be responsible for building and leading the safety and pharmacovigilance efforts for the Clinical Development organization. Development experience in oncology drug development, immune oncology agents, a plus.
$305,000 - $362,000 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Our Small Molecule Drug Substance Development and Manufacturing team has an opportunity for Scientist position to support our small molecule drug development pipeline. Work in a team of Arcus scientists and partner contract development and manufacturing organization teams to develop efficient manufacturing processes for small molecule drug substance preparation under GMP. The projects may encompass clinical stage candidates through commercial launch.
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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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Serve as clinical pharmacology lead and pharmacometrics representative on multiple project teams and support model-based drug development strategies for ongoing projects. Great working knowledge of formulation development, drug development and clinical development.
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As Pharmacy Drug Use Policy (DUP) Manager at Cedars-Sinai Medical Center, you will be collaborating with medical, nursing, pharmacy and healthcare team members on the development, maintenance and implementation of drug use policies, protocols and initiatives, drug information services and the Antimicrobial Stewardship Program.
$147,300 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Process Engineering, a part of AbbVie R&D’s Development Sciences organization, is responsible for designing and developing scalable processes to make small molecule drug substances and drug products, including antibody drug conjugates (ADCs), throughout pre-clinical and clinical development stages.
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The Senior Principal Scientist will collaborate across BMS sites with Analytical, Drug Product, Drug Substance, Quality, and Regulatory leads to execute drug product formulation/process development support, analytical strategies for drug product methods and specifications, analytical control strategies, and support of product development up to drug application submissions and approval.
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Minimum Two (2)+ years of hands-on laboratory experience in Drug product development. Drug Product Process Development. Lead experiments and laboratory activities to develop and/or optimize drug product formulation buffer.
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Evaluate and develop the most appropriate biochemical and biophysical characterization tools to support biological drug product development, including adjuvanted vaccine drug products.
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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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15+ 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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Represents Biomaterials & Drug Delivery to provide technical leadership for research and development programs. Aligns cross-functionally and executes study plans to advance a drug product through Discovery and early Development stages.
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Provide front line and independent process development expertise for clinical and commercial drug product manufacturing operations during sterile processing, process characterization, tech transfer, process validation, and on-going commercial manufacturing.
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In this vital role you will contribute towards Amgen’s Drug Substance Process Development for late stage clinical and commercial biologics programs, including the development, characterization, and scale-up of upstream and downstream manufacturing processes supporting Ph II/III clinical trials to marketing application.
$75,623 - $92,226 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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MD with 10+ years of experience in drug development and drug safety/pharmacovigilance, with specific expertise in clinical oncology, immunology, or genetics. Job Overview: This position is well-suited for a Medical Director with substantial expertise in drug development and safety, providing a unique opportunity to strategize the implementation of safety surveillance for clinical trials, oversee the management of safety signals, take charge of cross-functional teams, and contribute to the development of regulatory safety deliverables.
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drug development jobs Company: Genoskin
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