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Understanding of engineering, analytical and regulatory (current Good Manufacturing Practices (cGMP), filing, Environmental Health and Safety (EHS. The scientist will also ensure the transfer of robust manufacturing processes to CMO from Bristol Myers Squibb (BMS) Product Development (PD)/ Global Product Development and Supply (GPS) or CMO. The scientist will also ensure robust process performance at CMO during commercial manufacture by use of continuous process verification, Operational Excellence (OPEX) principles, etc.
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EXPERIENCE/EDUCATION: · B.S. in Science Field or related discipline is required (Chemistry or Bio Chemistry is preferred) · Knowledge in oligonucleotide synthesis and PCR technology is desirable · Knowledge in lab equipment automation and programming · Ability to work under cGMP guidelines, and coordinate/implement production schedule is necessary If interested, please share your updated resume at.
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The position will be responsible for supervising the training team who lead training activities for the overall plant team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing.
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The Sr Associate, Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements.
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The Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.
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Solid understanding of Good Documentation and Data Integrity Practices under cGMP. A solid understanding of the Veeva VAULT system is Required. Solid understanding of Good Documentation and Data Integrity Practices under cGMP. A solid understanding of the Veeva VAULT system is Required.
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Responsible to follow and maintain the cGMP and GLP. Ensure to follow the safety norms and adhere to company policy. Preparation & Review of configured Test plan, COA and compiled COA. Responsible to follow and maintain the cGMP and GLP. Ensure to follow the safety norms and adhere to company policy.
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Develop and approve cGMP documents including, but not limited to: Equipment and instrument Qualification, Commissioning, Master Validation Plans, SOP's, Comparability reports, Aseptic Process simulation protocols and reports; process validation (PPQ), and cleaning/sterilization validation.
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Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate BMS and FDA and European Medicines Agency (EMA) agency cGMP regulations and policies.
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Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis. This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements.
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A Minimum of 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
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7+ years experience in a GMP environment with knowledge of cGMP regulations and a background in microbiology. This is a multidisciplinary role & this individual will further interface across many parts of the company to develop novel products used in the cell therapy and gene therapy world.
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Experience within cGMP/FDA regulated industry. Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique. Production of blood component lots through cell culture, harvest, and cryopreservation.
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Ensure compliance with cGMP, Quality Systems Regulations, WIs, SOPs, and Health & Safety Requirements. Ensure compliance with cGMP, Quality Systems Regulations, WIs, SOPs, and Health & Safety Requirements.
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Review of documentation supporting batch, warehouse, metrology, engineering and validation activities to ensure they are complete and in compliance with company policies and procedures, and cGMP requirements.
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cgmp job in Piscataway, NJ
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