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Sr. Director, Biologics Drug Product MSAT page is loaded. Senior Director, Biologics Drug Product MSAT. We are accountable for direct technical support of drug substance and drug product operations, with responsibility for all aspects of process engineering: tech transfer, process validation, GMP manufacturing support, process monitoring and data analytics.
$237,660 - $307,560Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collate manufacturing process data to develop metrics, control charts and reports to improve manufacturing processesAssist with Supply Chain, Analytical, and Stability activities as neededReview/approve documents associated with Drug Product development and manufacturing, such as change controls, manufacturing batch records, protocols, investigations/deviations, and reports, and organize and archive documents in Veeva Quality Docs System.
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Oversee the drug substance, drug product, packaging/labeling/serialization, third-party logistics vendors for production activities of commercial and other late-phase therapeutic areas.
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Per the integrated CMC strategy, the candidate will represent Process Development in support of regulatory filing, clinical manufacturing, raw materials and logistics, and interface with ClinOps for drug product administration conditions.
$200,000 - $275,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Adverum is looking for an Associate Director / Director, Head of Drug Product Process Development (Drug Product PD) to join the Technology Development team at our Redwood City, CA office.
$150Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Collaborate with cross-functional departments (including Research, Pharmacology, DMPK, Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance) to implement discovery & development of toxicology strategies to enable the progression of optimized drug candidates and ensure that toxicological considerations are integrated into all stages of product development.
$225,000 - $260,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Collaborate closely with other departments, including Formulation and Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain, to ensure seamless integration of packaging processes with overall drug product manufacturing and distribution operations.
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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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The Director, Regulatory Affairs Advertising/Promotion will provide leadership, insight, and clear direction on all advertising and promotional programs and tactics that are compliant with regulations, aligned with approved product registrations, and company policies throughout the product life cycle.
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Advanced degree in Artificial Intelligence, Data Modeling, RNA sequencing, Biotechnology, Drug Discovery, Molecular Diagnostics or related field. Proficiency in data modeling, artificial intelligence, RNA extraction, RNAseq, generative AI, molecular testing, toxicology, molecular research, molecular cell biology, molecular DNA, bioinformatics, product design/development, project development, project design, and/or modeling.
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Jazz Pharmaceuticals is seeking an Associate Director, Biologics Drug Product (DP) Development to join our Biologics Development team. The successful candidate will have deep understanding of liquid and lyophilized formulation development for biologics, protein degradation pathways, biophysical characterization studies, drug product process development, tech transfer, process characterization, risk assessment and implementation of control strategies.
$156,000 - $204,750 a yearFull-timeRemoteExpandApply NowActive JobUpdated 4 months ago - UpvoteDownvoteShare Job
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As IT Product Manager for Medical and Drug Safety at Ascendis Pharma, your role will be to enable our global Medical and Pharmacovigilance (Drug Safety) teams with technology. You will partner with the medical and pharmacovigilance teams and lead the product discovery efforts.
$180,000 - $200,000 a yearFull-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Together these will include a wide sphere of influence to maximize Product Portfolio strategy and operation, the effectiveness and the interdependency of functions within PPS as a whole, as well as team effectiveness across the drug development functions and lifecycle from early stage to commercial launch and beyond.
$255,425 - $330,550 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Thorough understanding and working experience in drug product development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
$250,000 - $290,000 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago
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