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6+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, and bulk formulation. As Gene Therapy Manufacturing Supervisor, you will play a critical role in helping to establish REGENXBIO’s first internal GMP BDS and FDP clinical and commercial AAV gene therapy manufacturing capability.
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Manufacturing facilities are located in Dallas and Houston, TX; Decatur and Quincy,IL; Englewood, NJ; Fresno, CA; Nashville, TN; and Valdosta, GA. Corporate offices are located in Memphis, TN.We arecommitted to maintaining a progressive workplace by utilizing the ideas, skills and talents of all of our employees.
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The Manufacturing Supervisor is also responsible for providing leadership and oversight during component and equipment preparation, bulk drug formulation and aseptic filling duties.
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This position supervises manufacturing activities over the weekend 12-hour, day shifts of Friday, Saturday, and Sunday. Experience in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and regulatory/compliance standards.
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B.A./B.S degree in Chemical Engineering, Biology, or similar relevant field with at least 6 years of direct GMP manufacturing experience in a biotechnology manufacturing facility or Pilot Plant OR a High School Diploma with 10 years of experience in protein purification in Biotech/Pharmaceutical industry.
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A proven and qualified Supervisor will use knowledge and experience in upstream processing (seed expansion, bioreactor operations, cell culture harvest), downstream processing (purification and bulk filling) to teach others, troubleshoot, and continuously improve daily operations, and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities.
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Manufacturing Supervisor (Bulk Adjuvant) Bulk Adjuvant Manufacturing Supervisor. Preferred experience should include supervising and managing production including bulk manufacturing of medias and buffers using highly automated equipment, aseptic technique, input to scheduling and planning and regulatory compliance.
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Stratas Foods LLC is the leading supplier of fats and oils to the Foodservice, Food Ingredients and Retail Private Label markets in North America and is a producer of quality bulk and packaged dressings, mayonnaise and sauces.
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The Supervisor/Sr. Supervisor, Manufacturing, Floor Operations ( Supervisor ) leads a team of manufacturing associates to perform upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products.
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Tasks to be completed may include fermentation, protein purification, solvent extractions, tissue culture, preparation of bulk solutions, aseptic fills of buffers, filling and labeling of vials under sterile and non-sterile conditions, routine buffer and media preparation, filtration, vial preparation and sterilization.
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