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Comprehensive knowledge of biologic and drug development process, pharmaceutical technology, manufacturing processes, GMP, quality assurance & management and related issues, preferably in the areas of cell and gene therapy.
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Clean laboratory glassware following safety and GMP (Good Manufacturing Practices) regulations using a clearly defined procedure. Familiarity with Good Manufacturing Practices (GMP) is a plus.
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The ideal candidate should have relevant experience in cell therapy process development, technology transfer to GMP manufacturing and GMP principles related to cell therapy, and enjoy fast-paced, collaborative and vibrant startup culture.
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Reporting to the Director, QA Operations, the Manager / Senior Manager, GMP Quality Control is responsible for ensuring the compliance of generated QC data with Good Manufacturing Practices (GMP) both within the organization and generated by third parties.
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The manufacturing of oligonucleotide APIs in a GMP environment. Actively involved in aspects of technology transfer and scale-up of oligonucleotide manufacturing processes delivered from Manufacturing Technical Services into Manufacturing.
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We are looking for an experienced Scientist or Process Engineer to join our Manufacturing Science team, supporting TScan’s cell therapy manufacturing process development and GMP production of clinical cell therapy candidates.
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The selected candidate will have a detailed understanding of manufacturing processes, tech transfer, analytical testing, quality systems and GMP requirements for drug products and combination products.
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Coordinate multiple aspects of projects/processes within area (GMP/ECTL) with guidance, and execute processes (e.g., tech transfer & scale-up runs, HPLC/biologic assays, manufacturing of cellular therapeutics) utilizing appropriate techniques, equipment, and methods.
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Demonstrated background in support of GMP Quality management systems, General understanding of cGMP, ISO and ICH guidance’s in the biotech manufacturing environment. Will spend a portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines.
$80,000 - $81,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The selected intern will gain experience and understanding of both cell therapy testing and general QC support of GMP manufacturing practices. The Quality Control (QC) department is a Good Manufacturing Practices (GMP) function.
InternExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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The Secondary Loop Process Control Engineer provides technical leadership and automation support of manufacturing operations in accordance with appropriate Good Manufacturing Practices (GMP) and safety guidelines.
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1-5 years experience in viral vector/cell therapy (or biopharmaceutical) based GMP manufacturing operations including direct experience in cell culture, cell selection, recovery, purification, and/or aseptic fill/finish.
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The Procurement Manager will lead all facets of the procurement process supporting clients while driving activity to achieve desired outcomes at Amplify Bio’s new Cell & Gene Therapy manufacturing and development facility.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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The Sr. Manager will be responsible for leading all facets of Technology Transfer into manufacturing, GMP floor support and Continued Process Verification in accordance with current good manufacturing processes (cGMP.
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Bachelor’s degree in a Scientific, Engineering or Biotech field with 4 years’ experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance. HS Diploma or Associate’s Degree with 5– 6 years’ experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance.
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