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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.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Lead drug product development activities to advance new chemical entities (NCE) from the preclinical lead optimization stage through commercialization. Pharmaceutical Development, late-phase drug development, CMC, small molecule, GMP, ICH, FDA, EMA, New Drug Application.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Amgen is currently seeking a talented Process Development Senior Scientist to join our Drug Substance Technologies - Synthetics (DSTS) group at Thousand Oaks, CA. Amgens DSTS group within Process Development (PD) is responsible for the invention and development of drug substance manufacturing processes and technologies to advance Amgen's exciting portfolio of synthetic and hybrid assets.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Lead strategic communications counsel for and in support of the SVP, Heads of Drug Development for Immunology, CV and Neuroscience and Hematology/Oncology. Act as main point of contact for the SVP, Heads of Drug Development for Immunology, CV and Neuroscience and Hematology and Oncology in thought leadership initiatives designed to elevate the company’s scientific reputation in these therapeutic areas.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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This will include formulation and commercial process development for biologics (monoclonal antibodies, antibody drug conjugates, bispecifics and fusion proteins). The Biologics Drug Product Development group develops monoclonal antibodies, antibody drug conjugates (ADC), and other biologics using state of the art formulation and process technologies.
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The successful candidate will be instrumental in drug safety activities, supporting records management and compliance across clinical development and marketing programs. A minimum of 2 years of experience in a pharmaceutical industry setting within Drug safety, Pharmacovigilance, or equivalent.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Conduct/execute in vitro, ex vivo and/or in vivo studies to facilitate drug discovery and development with some independence. The Associate Scientist will be part of a team responsible for performing various analytical assays to support translational biomarker strategies for drug development candidates.
$65,000 - $78,000Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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As a Principal Scientist in our Analytical Development group, you will have a direct impact on the Arcellx drug pipeline, both as a thought leader and a lab-based contributor. 5+ years (with PhD) or 10+ years (with MS) of industry experience in cancer drug development.
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Frontage Laboratories is a CRO/Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Comprehensive knowledge of biologic and drug development process, pharmaceutical technology, manufacturing processes, GMP, quality assurance & management and related issues, preferably in the areas of cell and gene therapy.
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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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Background encompasses manufacturing process development of parenteral drug product, including oligos, protein, peptide, viral or cell therapeutics. Extensive experience in parenteral drug product process development.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Your primary mission as Scientist, Preclinical Development is to design and oversee experiments for validation (proof of concept) and development (IND enablement), to maximize scientific rigor in our drug discovery process.
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Head of CMC Operations (Drug Substance) will manage activities related to Process Development, Tech Transfer and Manufacturing of Drug substance. Managing complex and intertwined scientific/technical and operational logistical CMC related activities, the position will support the Company's drug development and manufacturing activities for phase 3 and commercialization at external Contract Development and Manufacturing Organization (CDMO) and Contract Testing Labs (CTL.
ExpandApply NowActive JobUpdated 9 days 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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drug development jobs Company: Ppd
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