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The candidate will be a part of the Biologics Drug Product Development team in support of Gene Therapy programs in the Genomic Medicine Unit. The incumbent will have the opportunity to work on different facets of drug delivery and product development for modalities such as Lipid Nanoparticles (LNPs) and Adeno-associated virus (AAV.
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The drug product development group supports the formulation and process development of Bristol Myers Squibb’s drug candidates from preclinical stage to commercial process readiness.
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You will provide technical and project leadership and work with cross-functional stakeholders to ensure pharmaceutical drug product development and CMC activities are executed seamlessly and in alignment with the integrated product development plan and program timelines.
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Playing a critical role as the subject matter expert (SME) and project lead of Pharmaceutical Development within CMC function, the position will be responsible for preformulation studies, formulation and process development, drug delivery design, optimization, scale-up and manufacturing in support of Revolution Medicines pipeline compound development and clinical programs.
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Playing a critical role as the subject matter expert (SME) and technical lead of Drug Product within PDM function, the position will be responsible for preformulation studies, formulation and process development, drug delivery design, optimization, scale-up and manufacturing in support of Revolution Medicines pipeline compound development and clinical programs.
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Support the development of the Drug Substance strategy and oversee manufacturing of preclinical and clinical material. Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team.
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This is a hands-on laboratory position in a fast-paced environment, with participation in cross-department collaborations towards advancing Genentech’s drug discovery and development. Strong experience and expertise in cell-based assay development, with proven expertise in cell culture, immunoassays and flow cytometry is required.
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Responsibilities Support the development of the Drug Substance strategy and oversee manufacturing of preclinical and clinical material. Senior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team.
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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.
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The Director, Drug Safety is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects of PV activities for products both marketed and in development.
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The Principal Toxicologist will be responsible for the design and execution of nonclinical development toxicology studies conducted externally, interpretation and communication of the toxicology data/reports to support drug development decisions, and for summarizing and writing regulatory submissions.
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PhD in Pharmaceutical Sciences, Biophysics, Biochemistry or a relevant discipline and 5 years of industry experience preferably in vaccine formulation development, or at least in biologics such as proteins or protein conjugates.
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The Role: Sail Biomedicines is seeking a highly motivated and innovative Associate Director, Drug Substance Process Development to be the subject matter expert and leader of RNA manufacturing processes, including upstream and downstream activities.
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The Senior Scientist will collaborate across BMS sites with Drug Product, Analytical, API, Quality, and Regulatory functions to execute drug product formulation/process development, formulation strategies, control strategies, and support of drug application submissions and approval.
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Reporting to the Vice President, CMC, the Director will manage and lead the Analytical development function ensuring the development and implementation of phase appropriate methods that meet international regulatory requirements for drug substance and drug product safety.
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drug development jobs Title: program manager Company: Ace Electric
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