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We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director of GMP Quality Control, who oversees GMP compliance of manufacturing, testing and release activities for SMPA, its partners, contract testing laboratories, and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases.
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Associate Director, GMP Quality Control. Experience in evolving GMP related quality systems, policies, and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
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Lead and/or present at the Stability and Specification Review Committees for GMP Drug Substance and Drug Product programs. Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products desired.
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Under the supervision of the Director of the Human Gene and Cell Therapy Facility (HGCTF), the HGCTF Lead Manufacturing Associate is responsible for the manufacturing of human gene and cell therapy products under Good Manufacturing Practices (GMP), quality control testing of these products to ensure that the products meet the required quality, supervise other manufacturing associates and overall management of all projects.
$6,566.67 - $14,583.33 a monthFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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With paid media execution, ad tech (GMP), tracking & analytics, dashboard creation (e. with D2C counterparts such as Sales, Go-To-Market, Product Management, dXp DTC, Growth Marketing, Email Marketing, Data Ops, Tech Dev, and Creative teams.
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Experience desired with drug delivery devices, diagnostics, biomarker, and genetic testing. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies.
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They also monitor the facility operation to ensure compliance with corporate quality requirements, SQF, labeling, GMP s, food safety, and all other such standards of the plant. The QA Technician will be an example for the line, as such they will need to be honest, dependable, punctual, and trustworthy and follow all policies/procedures set forth by Shearers Foods LLC. The QA Technician must have the ability to work well with others.
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Project lead for establishing Pilot Plant operations including building out the team to support process scale-up, implementation of new processes, and execution at GMP scale. Optimize pilot plant and pre-clinical production performance to allow for fast, flexible processing of multiple manufacturing processes including plasmid DNA prep, mRNA transcription and purification, and LNP formulation, and oligonucleotide synthesis.
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Responsible for supporting and maintaining the GMP clinical/commercial manufacturing and facility process equipment, Pilot Plant and QC laboratory equipment. Prior experience as a GMP Maintenance Technician in a complex pharmaceutical or biopharmaceutical manufacturing environment.
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Analytical Chemist" , Chromatography , HPLC ,MDI , "Metered Dose Inhaler" , DPI , "Dry Powder Inhaler" ,GMP , "Good Manufacturing Practice. Experience working in a GMP testing laboratory, and/or familiarity with relevant external guidance documents and cGXPs in support of analytical testing.
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Overseeing internal technical milestones, including research vector production, process/technology development, and GLP/GMP vector production. Overseeing internal technical milestones, including research vector production, process/technology development, and GLP/GMP vector production.
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Bachelor’s degree in a Scientific, Engineering or Biotech field with years’ experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance. HS Diploma or Associate’s Degree with – years’ experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance.
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Synthesize small organic molecules and perform routine analysis using HPLC, LCMS, FTIR, UV, NMR and other analytic instruments under a GMP environment. Hands-on experience with analytical and purification techniques, including UV, NMR, HPLC, LCMS, and flash purification systems.
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The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites.
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Analytical and problem-solving skills and willing to participate in rDMAIC. Knowledge of Microsoft Word, Excel and PowerPoint, and Electronic Quality Systems (Trackwise), LabWare, RAM, JDE Knowledge of FDA Regulations, Application of GLP, and Application of GMP. Complexity and Problem Solving Knowledge of Engineering processes, specifically, water systems, RO Systems and Alcohol distillation along with Metrology concepts.
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