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Utilize your extensive master data expertise to demonstrate a profound understanding of SAP MDG Materials, BOM, Recipes, MRP, MPS, Work Centers, Batch Management, Quality Inspection, Costing among others.
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You will closely collaborate with other development-functions (Toxicology, Bioanalytical, Non-clinical PK/PD, Pharmacometrics and Physiological PK/PD Modeling and Simulation, Biomarkers, Biostatistics and Data Management, Clinical Operations, and Clinical Development) to bring drug candidates from IND stage to NDA. You will be responsible for working within the department level budget and resources.
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The Candidate: Bachelor of Science in Analytical Chemistry/Pharmaceutics with equivalent industry experience Master of Science in Analytical Chemistry/Pharmaceutics preferred or more years of applicable industry experience in support of pharmaceutical product development Expertise in Instrumentation techniques: HPLC, GC, FTIR, UV, KF, and other wet chemistry testing.
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
$200 - $250Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Review/approve creation/modifications to Master Stability Protocols (MSP) and Study-Specific Protocols (SSP), batch-specific enrollment documentation, and LIMS stability studies. Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you.
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The DTS Business Process Owner will promote a manufacturing process excellence culture by identifying, developing and implementing program initiatives focused on manufacturing process improvement solutions within the highly integrated platform of SAP S4/HANA, SAP-ME, & LIMS. The individual will lead and direct the activities of Process Experts, Super Users, Specialists and Trainers (where they exist) and directly manage DTS process experts and master data stewards.
$70 - $80 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Senior Scientist, Clinical QC Bioanalytical will be a subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. Title: Senior Scientist, Clinical QC Bioanalytical.
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Skills and Qualifications:Bachelors Degree and enrollment in a Master of Divinity program from an accredited Seminary or Divinity School. Application should be submitted on the church's website - Summary:As the Youth and Young Adult Minister, youll serve as a vital support to the First Baptist Church of Lincoln Garden ministry focusing on pastoral care tailored specifically for children, teens, young adults, and those engaged in youth and young adult ministries.
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The New Jersey Judiciary consists of: the Supreme Court, the Superior Court including the Appellate Division and the Trial Court of the 15 vicinages in New Jersey, the Tax Court and the Municipal Court System.
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The Stability Senior Scientist reports to the Senior Principal Scientist or Associate Director of GBS and is responsible for end-to-end oversight of product stability programs. The Global Biologic Stability (GBS) team manages the stability programs for Bristol Myers Squibb’s commercial biologics Drug Substances and Drug Products.
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The Intelligent Automation Architect will work closely with cross-functional teams to identify opportunities for automation, design and implement solutions, such as automations for Clinical trial agreements, contract management, site management relates tasks, trial master file management, to streamline/speed up tasks and ensure their effective/secure utilization, faster completion, error/cost reduction and data quality improvement.
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Minimum 4 years of relevant work experience in Pharmaceutical Manufacturing System Processes (GxP) Systems environment and related Master Data Management. Develop and implement robust site Governance around E2E ERP Master Data, including defining and authoring local standardizations, SOPs, and work instructions.
$76,000 - $121,900 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), JMP, etc. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
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Join us as an Outsourcing Manager/BioMarker Operations Manager and play a crucial part in advancing our clinical biomarker and bioanalytical activities. If you meet these qualifications and are eager to contribute to a dynamic team, apply now and help us advance our clinical biomarker and bioanalytical initiatives.
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Our client, a leading pharmaceutical company, is hiring a Stability Associate Scientist, on a contract basis. The Global Biologic Stability (GBS) team manages the stability programs for commercial biologics Drug Substances and Drug Products.
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clinical trial master file jobs Title: master in Somerset, NJ
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