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The Scientist is responsible for instrument validation/repair/maintenance from user side, reagents management, performing cell based assay and impurity assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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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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In this role, you will define, implement and maintain the validation program for the site, ensuring compliance to the company quality guideline, FDA regulatory requirements, and cGMP regulations.
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Planning and overseeing cGMP pilot batches, including protocol, batch record, and report reviews. PhD in Pharmaceutical Science or a related scientific field with at least 7 years of experience in pharmaceutical formulation and product development.
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Technical expertise includes Column Chromatography, tangential flow filtration, cGMP compliance, SOP development, operational/workflow efficiency, process validation and technology transfers. Support technology transfer and/or process development through active participation in ensuring that new processes fit and execute consistently in the cGMP space.
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Bachelor’s degree with a minimum of two years’ experience or equivalent experience in Immunology, Microbiology, Molecular Biology, Biological Science, or another related scientific field. Assist with lab experiments, including tissue dissections, cell isolations, flow cytometry, imaging, and cell culture.
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Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.) The Senior Regulatory Affairs Manager ensures regulatory compliance of clients cosmetic, OTC, dietary supplement, and device products from brief through launch in North America.
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Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements (cGMP, FDA guidelines). Equipment Maintenance and Repair: Conduct routine inspections, preventive maintenance, and repairs on pharmaceutical manufacturing equipment, including but not limited to mixing machines, compression machines, encapsulation machines, coating machines, and packaging machines.
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Experience in Sterile drug product process development, Microbiology, Facility Engineering, Manufacturing, Supply Chain, Validation, and EHS Experience in the application of state-of-the-art laboratory equipment and software.
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5 Must be able to comply with cGMP requirements – hairnet, beard guard, no jewelry except for plain bands with no stones. 7 Polyethylene, polystyrene, PET, polypropylene, polyurethane and purging compound materials are both processed and ground, which provides some fumes and dust.
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REQUIRED: Bachelor's degree required preferably within the following disciplines (Analytical Chemistry, Organic Chemistry, Food Science, Food Chemistry, Microbiology, Biochemistry) Experience with GC, GCMS is preferred, with Flavors and/or Fragrance experience.
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Under the supervision of the Quality Manager / Quality Supervisor the QC Inspector ensures compliance with cGMP and company policies, procedures, and specifications. Minimum 1 - 3 years’ experience in Quality Control environment preferably in cosmetics, personal care, pharma, or food packaging industry with exposure to FDA and cGMP regulations.
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Follow line clearance requirements to maintain cGMP and cGLP in all work areas. Fermentation and/or protein purification experience, preferred. As a GMP Research Scientist, you will contribute to the development of potential GMP protein products and assist in establishing processes and procedures for their ongoing production.
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Bachelor of Science (B.S.) degree in Microbiology or Biological Science and/or at least Bachelor of Arts (B. A.) degree in Life Science with a minimum of two years of experience in a GMP laboratory environment or equivalent.
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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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microbiology cgmp jobs in Cranbury, NJ
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