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Working in a team setting, the Research Scientist I, will primarily be involved in Research and Development projects serving as a technical lead in translating research ideas and concepts into the product development pipeline towards development of diagnostic assay products.
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The successful candidate will function as a Product Owner and/or Release Train Engineer providing guidance and leadership of Scrum teams developing software components for intelligence data processing and analysis systems.
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Provides expert advice to product development team within CMC areas on all regulatory issues for the development, planning, compilation and submission of IND/CTA/MAA/NDA/BLA. Develops CMC regulatory plans to ensure optimal product development leading to the earliest possible approvals by relevant regulatory authorities.
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Representation of the Bioassay team within the Product Development department (Molecular Cloning, Protein Purification, Bioassay) as well as across departments including HR/Talent Acquisition, Marketing, Manufacturing, Business Development, QC and QA.
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We're looking for a highly motivated candidate to join our Product Operations Team and manage our Product Development Roadmap. We use Atlassian Jira, Confluence and BigPicture Roadmaps to document our product roadmap.
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You will work with experienced pharmacometricians, Preclinical Pharmacokinetics, Drug Metabolism, Toxicology, and Clinical Pharmacology colleagues to provide inputs to overall product development plans and to address research and development objectives and issues.
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Demonstrated experience and track record in clinical-stage drug development is a plus. The Pharmacometrics Group applies a range of model informed drug development (MIDD) approaches to support early and late-stage development of small and large molecules.
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Independently conducts PK/PD analyses of data from Phase 1/2 studies and application of quantitative decision-making to assist in the characterization of population PK, dose- and exposure-response relationships to optimize subsequent clinical development.
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Leads the engineering product development process through major program milestone reviews (SRR, PDR, CDR, TRR, etc), in addition to helping establish the overall review plan. Supports technical leadership on product design, development, and improvement projects in concert with Program Management.
$116,480 - $208,505 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Manager or Senior Manager Development Engineering will support Engineering consultant SOW, Bid Set design reviews, and EPC technical exhibit redline reviews. Origis Energy is seeking a Manager or Senior Manager Development Engineering to provide technical support and management for early-stage conceptual design and optimization in renewable energy projects as they flow from inception through EPC contracting.
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The Affordable Housing Development Coordinator, under the general direction of the Project Manager I/II, HRED, performs a wide variety of tasks directly related to the development and preservation of affordable housing.
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This position requires a seasoned professional with a deep understanding of nonprofit development, a proven track record of successful fundraising, and a compassionate understanding of autism and ARI’s work.
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Lead method development, transfer, qualification, and validation of QC-friendly product release methods. Requirements Requirements, Knowledge, Skills and AbilitiesPh. D. in biochemistry, biophysics, chemistry or other related scientific discipline with 8+ years of industry experience in analytical development for biologics and gene therapies (an equivalent combination of education and experience may be considered.
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Responsibilities include but are not restricted to the following: collaborate with R & D for new product transfer and consult to resolve issues with QC test strategies; collaborate with manufacturing, process engineering and QA for non-conforming product troubleshooting and resolution; develop strategy, organization, including process improvement to ensure the Quality Control meets business expectations.
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In addition, the Manager Drug Product Development and Manufacturing will support all aspects of non-GMP and GMP drug product manufacturing and ensure that the CMC team is aligned with the manufacturing strategy at each CMO. A strong knowledge of sterile parenteral filling and the requirements of clinical supply manufacturing is required as well as a working knowledge of cGMP and FDA/EMA guidelines.
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product development jobs Title: account manager Company: Siemens Energy in San Diego, CA
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