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Authors regulatory submission documents for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA), supplements, annual reports and Investigator Responses (IR)/Complete Response Letters (CRLs), covering pharmaceutical development and manufacture, including product development reports.
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As the Associate Director-Capital Procurement, you will play a pivotal role in planning, sourcing, and driving strategies related to drug product, device assembly, packaging, and robotics equipment.
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Represents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo.
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Respond to customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel (e.g., sales, clinical research, marketing, product development) to develop optimal solutions.
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Leads product development teams responsible for novel Hematology Oncology therapies from preclinical candidate selection through proof of concept leading to Phase 3 investment decisions.
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Labcorp Drug Development Data & Digital Solutions (D&DS) is currently in search of Product Manager to drive Discovery and Solution development for a family of products. Support development of product funding plans with internal functional partners and collaborate to achieve agreed revenue, volume, and margin targets.
$104,200 - $143,300 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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The service portfolio supports all stages of the drug development process and all functional areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality control.
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Director for Downstream Process Development, you will develop, design and transfer downstream processes for a variety of product candidates spanning early and late stage development and multiple modalities (including complex Fc fusion proteins, mAbs and mRNA) at Shattuck Labs. You will lead the downstream process development team and coordinate efforts with multiple teams across R&D and Technical Operations to deliver downstream processes for our pipeline of drug candidates.
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Technical understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP formulation, DP Filling, Inspection. Owning Change Controls to introduce new products to Clinical and Commercial Drug Product inManufacturing facility.
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Product defense before a national or international regulatory authority a plus Drug safety database knowledge preferred Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat computer skills Must have excellent communication skills (verbal and written) Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
$146Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Associate Director Category Management will be responsible to develop & own the Global Category Management strategy for the Drug Product, CMO, Packaging Component, Equipment & Facilities, and other areas as assigned.
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Solid understanding of scientific principles and regulatory requirements relevant to global drug and drug-device combination product development, registration and post-market support.
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Scientist – Immunogenicity Full Time Exton PA or Spring House PA Frontage Laboratories 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.
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Green Peak Innovations and Skymint are looking for passionate and compassionate people to work in the next great American industry, where our commitment to the cultivation, development and sale of safe and quality product is our top priority.
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Duties vary, including but not limited to: product development projects, machine build projects, 3D printing and machine maintenance, CAD work, presentations, tutorials, brainstorming sessions, meetings, record keeping (notes and database updates), and general ingenuity.
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