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Industry giant seeks an experienced Process Development Scientist to develop protein purification processes to be scaled up and transferred into cGMP manufacturing including evaluation of transferred processes, transfer of processes to manufacturing, harvest clarification, normal flow filtration, purification, tangential flow filtration, and product final formulation.
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Basic proficiency operating several of the following pieces of equipment: Formulation tanks and associated equipment Scales Liquid and solid dose filling equipment Bottle Unscrambler Cottoner/Coil Inserter (if applicable) Capper, Torque Tester Induction Sealer/Foil Seal Detector Labeling equipment (e.g. Labeler, Topserter, etc.
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Preferred Attributes: Experience with, completion of, or understanding of: 4 years in manufacturing/operations with 2 years in supervisory role cGMP standards and FDA (or other industry) guidelines for production STEM degree or certification Aseptic filling, single use assemblies, isolator technology.
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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. Coordinate daily operations and lead on the floor manufacturing employees to complete production activities safely and compliantly in accordance with OSHA and cGMP guidelines.
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Evaluate the effects of formulation variables and factors for optimizing efficient sterile filtration Required Skills/Education:Undergraduate or graduate student in chemistry, biochemistry, chemical or bioprocess engineeringMust be at least a 2nd year student and a returning student this fall.
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Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) Responsible for maintaining all manufacturing equipment including formulation, filling and packaging equipment, and plant utility systems including boilers, air compressors, heating, ventilation and air conditioning systems (HVAC), Water for Injection (WFI), and general upkeep of the physical plant including clean rooms.
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The role of a Manufacturing Technician is to perform all tasks associated with formulation, preparation, assembling, and packaging of components, according to cGMP Guidelines to meet production demands.
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Sound knowledge of cGMP practices as applicable to process development, scale up, technology transfer, formulation development, and Manufacturing. Provide expertise for the scale up, tech transfer, and validation, of upstream cell culture and viral vector unit operations to internal and external partners in support of clinical/commercial manufacturing of.
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Demonstrated ability to lead and/or author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required. The Quality Control Analyst compiles data for documentation of test procedures that may include stability program testing and formulation studies, participates in the preparation of investigations, summaries and reports, and reviews data obtained for compliance to specifications and reports out-of-trend and/or out-of-specification results.
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The Processing Technician is responsible for manufacturing bulk blend product and must be competent for most job categories required in the Processing Area. The Process Technician is required to have the knowledge to perform set-up, operation, tear-down, cleaning, following cGMP s and SOP s.
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Bioprocess cGMP experience; harvest clarification, downstream processing, bulk fill, formulation and filling, PUPSIT etc. Bioprocess cGMP experience; harvest clarification, downstream processing, bulk fill, formulation and filling, PUPSIT etc.
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Supporting all aspects of Production for sterile drug products, overseeing Production Technicians and performing technician duties such as batch kitting, formulation, aseptic filling, inspection and labeling.
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They’re seeking a talented Senior Formulation Scientist to join our dynamic team and drive innovation in the Over the Counter (OTC) pharmaceutical and supplement markets. The Senior Formulation Scientist will play a pivotal role in designing and developing novel confectionary-based OTC drug and supplement products.
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Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design.
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The ideal candidate will serve as the process subject matter expert in cell expansion, isolation, cryopreservation and final formulation for clinical manufacturing for cell therapies, bioprocess development, and cGMP manufacturing.
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