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The heart of insitro's strategy is the combination and application of machine learning to disease biology at scale, and novel analyses from clinical and cellular datasets that address key shortcomings in the target discovery and drug development process.
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Downstream Bioprocess - Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance and drug product for clinical and commercial manufacture.
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Strong experience in synthetic small molecules, peptide or oligonucleotide method development, characterization, and analytical control strategy. Amgen is currently seeking a Process Development Sr Principal Scientist in our Pivotal Attribute Sciences Department in Cambridge, MA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.
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Understand the process control strategy for AAV and gene therapy products. Understand the scientific principles required for manufacturing AAV drug substances and products, and have extensive hands-on experience on chromatography operation, TFF, viral filtration and sterile filtration.
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As an Associate Digital Product Manager in IT & Digital, you will have a critical role in overseeing the product strategy, development/implementation and management of technology products in different focus areas in Global Drug Safety and Pharmacovigilance.
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Using the Product Oriented Delivery (POD) model, ensure its success and application in the development/implementation and utilization of technology products across the value chain of Global Drug Safety and Pharmacovigilance.
$114,375 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Serve as an experienced thought leader for Immuno-Oncology & Translational Oncology within Takeda, guiding the research strategy and ensuring its successful execution while supporting talent development as a strong mentor and role model for cell engager research.
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The Campus Development Division delivers the PNNL campus strategy to provide laboratory facilities and infrastructure aligned with our cutting-edge science and technology research mission.
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Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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The team is led by our CMO, a physician and medical oncologist with over 25 years of experience in large pharma and biotech drug development. We will consider a Ph. D. with 12 years or more experience in drug development roles in a pharmaceutical industrial R&D setting.
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Serve on cross functional drug product (DP) working group and supports DP activities through filing and Process Performance Qualification (PPQ), site characterization plan and execution, tech transfer control strategy, process development, PPQ readiness, PAI (Pre‐Approval Inspection) readiness, approval, launch and post‐launch support.
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Required Skill/Ability 3: Demonstrated experience in creating database specifications and building studies in one or more Electronic Data Capture (EDC) systems ( Medidata Rave, Oracle InForm, IBM Clinical Development, Medrio, REDCap, etc.
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The KAM works with his/her assigned Regional Director and Field Reimbursement Manager to develop a strategy and business plan that maximizes the opportunity in the territory. This is done through development, cultivation and maintenance of long-term relationships with ophthalmic surgeons and all relevant personnel at physician practices/clinics and ambulatory surgery center accounts.
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Seeking an entrepreneurial, strategic, driven, and visionary scientific leader to join our team as VP, Biology and Translational Research reporting to EVP, Chief Drug Discovery and Pre-clinical Development Officer.
$310,000 - $335,000 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Individual must have prior project regulatory leadership experience with specific focus on the CMC aspects for small molecules, large molecules and/or cell/gene therapies, including detailed knowledge of FDA and EMA regulations and guidance for drug development, preparation and management of IND/CTA/MAA/NDA/BLA. Prior experience with preparation and preferably, negotiation to marketing approval in major markets is desirable.
$167,000 - $241,925 a yearFull-timeExpandApply NowActive JobUpdated Today
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