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Represents QC Analytical Development on internal and external tech transfer meetings related to the introduction of new materials for the manufacture of biological drug substances and drug products.
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Basic knowledge of medical terminology and a working knowledge of drug development services desired; We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.
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Minimum 3 years of experience in data programming experience in SAS or R including 2 years in drug development, CRO or other clinical research setting. Minimum 2 years of experience in drug development and/or clinical research.
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Thats why we offer competitive wages and a wide range of benefits, including medical and dental insurance, prescription drug card, 401K and pension plans, flexible dependent care and medical spending accounts, spouse and child life insurance, employee referral bonus, and discounts with Penske partners.
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In this vital role you will be a part of the Process Development Drug Substance Technology group at Amgen’s FleX Batch Biologics Manufacturing Facility. Engineer Upstream, Process Development.
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The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
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Prior drug substance and commercial manufacturing experience, including late stage process development, validation, and tech transfer. Provides Upstream / Cell Culture technical support for troubleshooting, process assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviations.
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In this vital role you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen’s FleX Batch facility. Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing.
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The Process Development Associate will help design and perform experiments at the bench scale that span the end-to-end Drug Substance process, covering cell culture and/or purification operations.
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Basic knowledge of medical terminology and working knowledge of drug development services; Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach.
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With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Execute drug safety data management processes – a combination of call intake, call dialogue documentation, peer review, case follow-up, report preparation and submission to regulatory authorities.
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