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MS or PhD in Chemistry, Pharmaceutical Science or related field. It offers services in the areas of custom synthesis/contract research, process and analytical research, cGMP synthesis, crystallization process development, solid form screening and selection, pre/early formulation, and drug substance-drug product coprocessing.
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B.A./B.S degree in Chemical Engineering, Biology, or similar relevant field with at least 6 years of direct GMP manufacturing experience in a biotechnology manufacturing facility or Pilot Plant OR a High School Diploma with 10 years of experience in protein purification in Biotech/Pharmaceutical industry.
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PhD in Pharmaceutical Science or a related scientific field with at least 7 years of experience in pharmaceutical formulation and product development. Bachelor's degree in Pharmaceutical Science or a related scientific field with at least 15 years of experience in pharmaceutical formulation and product development.
$125,000 - $145,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Recombinant Proteins Group unites deep scientific expertise with a collaborative culture to build a product portfolio that includes cytokines, growth factors, antibodies and ELISA kits used to support the research of our academic, government, biotech, and pharmaceutical customers.
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SAP, cGMP practices, Microsoft Office (Outlook, Word, Excel, PowerPoint); Thorough understanding of pharmaceutical supply chain management, managing and leading an organization’s transportation strategies & global supply chain and logistics, and Lean/Operational Excellence best practices; Must be familiar with documentation required for filing ANDA’s.
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General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
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Bachelor’s Degree required plus six (6) years of experience in cGMP Pharmaceutical Manufacturing or Packaging setting as a production manager or team leader; or a High School Diploma or GED and ten (10) years of experience in cGMP Pharmaceutical Manufacturing or Packaging setting as a production manager or team leader.
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Bachelors degree in Engineering, Packaging or related science field and minimum 5 years package engineering, package development and/or technical support of existing packages in the pharmaceutical, biotechnology or related cGMP regulated environment.
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Bachelor’s degree in Pharmaceutical Science or related field with a minimum of 9+ years of experience, Master’s degree with 7 years of experience, or PhD with 4 years of experience in pharmaceutical formulation and product development.
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5+ years of work experience in Quality Assurance or Regulatory Affairs in a cGMP pharmaceutical and/or biological manufacturing regulated environment preferred. uthor, review, and approve cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents.
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Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.
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Support manufacturing sites with process engineering and facility designs for strategic projects including development of User Requirements, technology evaluations, equipment selection, cGMP considerations and regulatory compliance.
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Knowledge of cGMP standards and regulatory requirements in the pharmaceutical industry and a detailed understanding of the principles and concepts in relation to drug substance development.
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High school diploma or equivalent AND minimum 3 years experience as a maintenance/mechanic or related specialty working in a cGMP regulated environment in a pharmaceutical or biotechnology facilities, consumer products, packaging and/or manufacturing department(s) REQUIRED.
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Electronic Records & Electronic Signatures (Part 11), cGMP Bachelors Degree with a concentration in IT/Computer Systems 4 to 5 years of experience in Pharmaceutical industry or computer systems management Good knowledge in cGMP environment.
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pharmaceutical cgmp jobs in Hightstown, NJ
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