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Primary Responsibilities:Provide technical leadership and subject matter expertise to the Nucleic Acids testing team to ensure the successful execution of all GMP release and stability PCR testing executed in support of Sarepta’ s Gene Therapy programs (currently 1 commercial program and 5+ active clinical programs.
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2-3 years of experience working with analytical and biologic methodologies (chromatography, HPLC and ELISA in a regulated GMP/GLP Lab environment) HPLC, GC, KF, and UV/Vis. This position will also be working part of the time in the lab as the expert on HPLC and Empower in a GMP lab setting.
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They will look to maximize the ROI of the system, streamline business processes, and ensure GMP compliance. The ERP Manager will oversee the implementation and ongoing maintenance and upgrades of the Microsoft Dynamics 365 Finance and Operations enterprise resource planning systems within the organization.
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The Associate Director, QC Cell Culture and Bioassay will be responsible for overseeing a testing laboratory charged with the execution of all GMP bioassay testing (release and stability) related to Sarepta' s Gene Therapy pipeline.
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The Expression group is responsible for non-GMP protein drug lead generation, supporting the various Pfizer research units and their pre-clinical therapeutic in-vitro and in-vivo needs. The Expression group is responsible for non-GMP protein drug lead generation, supporting the various Pfizer research units and their pre-clinical therapeutic in-vitro and in-vivo needs.
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Previous experience in Biologics GMP manufacturing and/or Biologics Tech Transfer. Lead/support the creation of manufacturing batch records and other GMP documentation. Experience in a GMP manufacturing role.
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Assist w/ controlled doc sys, incl prep + revise SOPs. Lead/assist w/ cont improv initiatives for all GMP funct. Must have Bach in Biology or rel sci field and 2 yrs rel exp working in a GMP environment in the pharmaceutical industry or in the biotechnology industry.
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Work closely with QA to ensure GMP activities are conducted in accordance with internal QMS. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
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Maintain written records of all experimental work in accordance with Good Lab Practices / (Current) Good Manufacturing Practices (GLP/GMP) and departmental Standard Operating Procedures. Experience in a (Current) Good Manufacturing Practices (part of GMP) Laboratory.
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A minimum of 5 years’ experience in a GMP manufacturing environment with a bachelor’s degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field.
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Filling, Gmp, Sop, Inventory Control, Six Sigma, pipetting, Reagent, biotechnology, microbiology, microbiologist. GMP and SOP procedures. Filling, Gmp, Sop, Inventory Control, Six Sigma, pipetting, Reagent, biotechnology, microbiology, microbiologist.
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5-10 years' experience in maintenance planning, scheduling and/or MRO inventory management in a GmP environment. Ensures GMP and non-GMP maintenance work is completed and documented in the most efficient and compliant manner in alignment with Lantheus Quality Management Systems.
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The Technical Operations Specialist will assume responsibility for internally overseeing the manufacture and completion of client project activities to support release of products for clinical trials and ensure the delivery of batch manufacture and documentation to GMP standards, in line with client project timelines.
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GMP Aseptic and non-Aseptic Areas and Non GMP Area Offices spaces. The Apprentice Telecom Technician will participate in the installation or maintenance and inspection of telecommunication systems and associated process along side a licensed Telecom Technician.
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Test continuity of circuit to insure electrical compatibility and safety of components, using testing instruments, such as ohmmeter, battery and buzzer, and oscilloscope; Measures, cuts, bends, threads, assembles and installs electrical conduit, using such tools as hacksaw, pipe threader and conduit bender.
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gmp job Company: Genoskin in North Reading, MA
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