- Exela Pharma Sciences, LLC (Lenoir, NC)
- …topics to a non-technical audienceAt least 8 years' experience in the biotech/ pharmaceutical industry in validation , quality management, process controls, and ... Position Summary:Oversee and lead the validation program for production equipment and processes used...manufacturing of aseptic and terminally sterilized products. Lead the validation team in the establishment and maintenance of validated… more
- Merck & Co. (Durham, NC)
- …supporting the pharmaceutical manufacturing industry, specifically in pharmaceutical operations, technical operations, validation and/or process Quality ... in the coordination of resources and equipment pertaining to qualification/ validation activities supporting the vaccine expansion facility.Primary Responsibilities:The Quality… more
- Novo Nordisk Inc. (Durham, NC)
- …barriers preferred Knowledge of LEAN principles required Experience with relevant pharmaceutical engineering disciplines, incl. validation concepts (GMP) desired ... for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Cleaning Validation Lead as part of the Technical Operations team based in Raritan,… more
- Aequor (Libertyville, IL)
- …new business systems and practices, primarily GxP.Understanding of computer system validation and experience using IT service management platforms (QMS) to support ... managing IT deviations, CAPAs, Investigations, Change Management, and computer system validation in support of the vector manufacturing site.The candidate should… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …writing abilitiesUnderstanding of aseptic processing techniques preferredKnowledge of pharmaceutical product development, manufacturing processes, validation , ... used for the manufacture of terminally sterilized and aseptically filled pharmaceutical products into vials, syringes and IV bag formats. Job Responsibilities:… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …or more years relevant work experience in cGMP related industry and/or Pharmaceutical Microbiologically.Experience with validation of sterile processes would be ... advantageous.Education RequirementsBachelor's degree in science, engineering, or other related technical field. more
- Aequor (NV)
- …Viral, and General (compendia) Direct experience with method transfer and method validation processes from a Pharmaceutical or Biotechnology Company. Knowledge ... of pharma/biotech experience *Biotech/ pharma experience required) * Analytical method validation and transfer experience Ideal candidate with a bachelor's degree in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders… more
- Merck & Co. (Lower Gwynedd, PA)
- …limited supervision to all aspects of assay development, qualification/ validation , technology transfer, and/or troubleshooting.- Preferably, the successful candidate ... track record for developing assays capable to meet Regulatory expectations for validation and line of sight for life-cycle maintenance.-Job Location: SHIP, PA Main… more
- Merck & Co. (Rahway, NJ)
- …This research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development ... Division and our Manufacturing Division - in particular Discovery Pharmaceutical Sciences, Biologics Analytical Research and Development (BAR&D), Bioprocess research… more
- AUROBINDO (Durham, NC)
- …group of companies with a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10-year history of extraordinary ... organization have given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management… more
- Merck & Co. (Rahway, NJ)
- …to internal and external manufacturing sites, manufacturing investigations, process validation , and authoring of regulatory submissions. -Under the general ... process enhancements, next generation process development and characterization, process validation , and regulatory submission authoring. In this role, the successful… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …site GMP Clean Utilities infrastructure and systems (WFI, Clean Steam, Pharmaceutical /Oil-Free Compressed Air, Process Gases, HVAC, etc.) and applications in aseptic ... associated within their facilities) and understanding their applications in pharmaceutical aseptic manufacturing.You will provide technical SME support for… more
- Novo Nordisk Inc. (Durham, NC)
- …for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our ... weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards… more
- Merck & Co. (Rahway, NJ)
- …team. The individual will play a critical role in the development and validation immunoassay-based assays that are deployed in support of clinical trials. The ... should have a strong interest in lab-based assay development, validation , and clinical sample analysis. In addition, the candidate...or 5 (for MS) years of clinical laboratory or pharmaceutical industry experience, or a doctoral degree (Ph.D.) in… more
- Merck & Co. (Rahway, NJ)
- …for applying their knowledge of product and process development in the (bio) pharmaceutical and/or medical device industries to set tactical and strategic direction ... of product design and development; manufacturing process development, qualification, and validation ; and design control and risk management techniques to positively… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for architecting and coordinating the design, installation, commissioning, startup and validation of all assigned new capital improvement projects. Primary the ... the execution of projects from design through construction, commissioning, start-up and validation , ensuring that projects run on schedule, are cost effective and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... informatics project management, SDLC Quality Model, subject matter, and computer system validation guidance to Global and Regional IT system owners so they can… more
- Novo Nordisk Inc. (Durham, NC)
- …for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our ... weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance Life & Disability Insurance Employee Referral Awards… more
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