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Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions.
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6+ years (with MD or PharmD) in pharmacovigilance, drug development or applicable role in the pharmaceutical industry with significant knowledge of relevant regulatory requirements and substantial knowledge of drug safety including previous experience in a leadership role in the pharmaceutical industry.
$274,635 - $355,410Full-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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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 Today - UpvoteDownvoteShare Job
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Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
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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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The individual may be requested to represent the Toxicology Department at drug development project teams to convey aspects pertaining to the quality, occupational and/or environmental health risks of experimental and/or marketed medicines.
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Revolution Medicines is seeking a motivated individual with a scientific background to play a critical role as the strategic sourcing and supplier management lead for drug product and finished product within the Pharmaceutical Development and Manufacturing (PDM) function.
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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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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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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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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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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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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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