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Responsibilities Ensure compliance with cGMP, Quality Systems Regulations, WIs, SOPs, and Health & Safety Requirements. Responsibilities Ensure compliance with cGMP, Quality Systems Regulations, WIs, SOPs, and Health & Safety Requirements.
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Knowledge of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and regulatory pharmaceutical marketing and manufacturing principles, practices, and their application is preferred.
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Must be familiar with proper cGMP practices for analytical laboratories and working knowledge of basic laboratory instrumental analysis and wet chemistry skills. Must have cGMP compliance knowledge and experience.
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To support further expansion we seek a Downstream Processing Scientist who is responsible for the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment.
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Understanding of formulation development, manufacturing processes, and experience in pharmaceutical R&D and cGMP Manufacturing Operations is a plus. Ascendia’s technologies include nano-emulsions, amorphous solid dispersions, nano-milling, injectable, lipid nanoparticles, and oral controlled release.
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Issue, assembly and review of documentation supporting batch, laboratory, warehouse, metrology, engineering and validation activities, to ensure complete and in compliance with company policies and procedures and cGMP requirements.
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Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatoryrequirements at all times. It’s the ripple effect that changes and improves everything for your family, your community, and the world.
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This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements. The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment.
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Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
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Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional). Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.
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Cleans up and removes garbage from various locations throughout the company, including current Good Manufacturing Practices (cGMP) areas. The Facilities Porter is part of the Facilities Maintenance team and is responsible for cleaning designated plant operating areas, rest rooms, labs, cafeterias and offices in order to assure the preservation and upkeep of the buildings, fixtures, and resident spaces of the organization.
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The Downstream Manufacturing Scientist is a hands-on position responsible the purification of 50L to 1000L volumes of clinical and commercial batches in a cGMP environment. Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
$45 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Essential Duties & Responsibilities Perform and supervise downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis. Job Type Full-timeDescriptionThe Downstream Manufacturing Manager is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars.
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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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Keeps manufacturing , lab, cafeteria and office areas clean at all times. Empties plastic bags from trash receptacles, tie and transport. Previous Porter or Housekeeping experience PREFERRED. She/he complies with instructions and prescribed routines, methods or cleaning and disposal procedures in accordance to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs.
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cgmp job in New Brunswick, NJ
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