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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 drug product development activities to advance new chemical entities (NCE) from the preclinical lead optimization stage through commercialization.
$108 - $118 an hourFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Leading analytical method development and execution for Drug Product characterization including direct management of junior scientists. Evaluate and develop the most appropriate biochemical and biophysical characterization tools to support biological drug product development, including adjuvanted vaccine drug products.
$152,000 - $170,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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We are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects.
$241,366 - $341,670 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Senior Product Marketing Manager position will report to the Director of Product Management. This individual will be responsible for driving product and application-based messaging across Twist’s business units, including core initiatives toward cancer research, drug discovery, and human genetics.
$120,000 - $170,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Clinical Trials Management Associate will work closely with Technical Operations to ensure drug product quality and delivery, Translational Sciences to ensure timely site biomarker sample collection and shipments, and support the clinical operations team with TMF filing and other duties as assigned.
$93,500 - $114,500 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Your extensive experience and expertise in Neuroscience drug development will play a pivotal role in shaping the future of our research endeavors! Ph. D. in Immunology or Neuroscience with over 20 years in academia or in the biotech/pharmaceutical industry, including 10+ years in drug discovery.
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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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Participates as a member of the Study Management Team and acts as a safety liaison between the Drug Safety department and key stakeholders in other Iovance functional groups. Provides safety review and input into safety sections of clinical documents, including but not limited to investigational brochures, study protocols, informed consent forms, briefing documents, clinical study reports, risk management plans, product labeling, and IND/BLA packages.
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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.
$150Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Experience in leading the design and implementation of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.
$152,792 - $172,833 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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The Product Management for Lab operations software / Lab information management system (LIMS) will be responsible for one or more components of Natera’s Laboratory Management Software product strategy and development to support laboratory operations of Natera’s tests.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Experience in late-stage drug development, including putting together data and documents towards, authoring/reviewing, and submitting an NDA for a small molecule commercial product highly preferred.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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We work with companies funded by the best investors including Sequoia Capital, Lightspeed Ventures, Tiger Global Management, A16Z, Accel, DFJ, and more. You should have a strong ability to build meaningful connections with high value consumers, forge brand partnerships with sales influencers and companies on social, and create buzz on social around our product.
$20,000 - $70,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - 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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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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product management drug jobs Title: development director Company: Omeros in San Mateo, CA
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