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This position performs laboratory scale development activities for the purification of pre-clinical and cGMP grade rAAV vectors. Experience with laboratory scale purification equipment such as AKTA, TFF systems, and depth filtration equipment is desired.
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The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
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Bachelors, or Masters, degree in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 3 years of experience, or 2 years with Masters degree, preferably in a GMP QC laboratory setting.
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Strong analytical and problem-solving skills, with demonstrated knowledge of statistical methodologies within a cGMP/GLP regulated quality system. Minimum 2+ years of laboratory experience in assay or product development in a biotech or pharma setting is required.
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The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
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Vor Bio is seeking an experienced Quality Control Senior Analyst to be a part of the team responsible for the day-to-day operations assigned to the QC Microbiology group, including sampling of a cGMP manufacturing facility, testing samples in the QC Microbiology laboratory for batch release of advanced therapeutics including cellular and gene therapy products.
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Perform analytical testing and data review of batch release, in process and/or stability samples of mRNA drug substance in cGMP compliant laboratory. This candidate will be responsible for laboratory activities in support of process development and industrialization and ensure the characterization of mRNA. These analyses include HPLC, ELISA, qPCR, western blot and more that support the process development.
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Lead Root Cause Failure Analysis (RCFA) and Failure Mode Effect Analysis (FMEA) in cGMP, biotechnology environment. Knowledge of laboratory and pharmaceutical process support equipment including CIP, SIP, Autoclaves, Glass Washers, etc.
$84,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Understanding of process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA is desirable. Knowledge of the core engineering principles of heat transfer, mass transfer, thermodynamics and fluid mechanics.
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Understanding of Reliability Centered Maintenance (RCM) and/or Total productive Maintenance (TPM) is desirable. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
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The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
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Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc. Minimum 6-8 years related experience in a pharmaceutical manufacturing environment. Strong knowledge of instrumental and wet analytical chemistry.
$110,000 - $120,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Required) Familiarity with cGMP regulations and industry standards for biopharmaceutical manufacturing. Why Join Us: Supportive management invested in your success Opportunity to learn new skills and grow your career Experience at a brand name, highly recognizable global organization Skills:GMP, mRNA, Laboratory/Sciences Experience:Entry Level responsibilities: Key Responsibilities: Execute manufacturing processes for mRNbased products, adhering to standard operating procedures (SOPs) and batch records.
$32 - $34 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Associate Director of Quality Operations is responsible for ensuring our Quality organization meets all compliance requirements pertaining to Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), FDA, ICH and EMA regulations.
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To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.
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cgmp laboratory jobs in Lexington, MA
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