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We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
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Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred.
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About Research Models & ServicesFundamental to basic research and discovery is the use of in vivo models to help identify disease targets and determine potential biological pathways that regulate the condition.
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Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture. 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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Strong background in GLP and cGMP standards, with hands-on experience in assay development and validation. Strong background in GLP and cGMP standards, with hands-on experience in assay development and validation.
$32 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Lead investigations into significant quality issues, scientific misconduct and suspected serious breach of GCP or GLP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate.
$200,000 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Working knowledge of cGMPs, GLPs Strong knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with parenteral drug manufacture.
$118,000 a yearExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Strong knowledge of engineering standards and all applicable regulatory requirements including: Building Codes, Factory Mutual, Environmental, GMP/GLP, OSHA and ADA. Minimum of 10 years demonstrated Project Engineering & Management experience leading cross-functional project teams for design, construction, commissioning & qualification, and start-up with a proven track record of on-time & on-budget performance for complex projects related to Pharmaceutical Manufacturing Facilities.
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Successful candidates will be responsible for contributing to Fractyl’s lead and pipeline programs with a primary focus on design, management, execution, analysis, and data reporting of non-GLP and GLP in vivo studies to evaluate delivery, efficacy, safety, and pharmacology of AAV-gene therapy candidates in various animal models.
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GMP, GLP, CPR, spill containment, IATA, DOT, IMDG, Hazwoper, and/or OSHA training is desired. Manage other lab-related services (i.e., freezer de-icing, BSC and incubator cleaning, glass wash and autoclave) to ensure their successful and timely completion daily.
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The Principal Toxicologist will work closely with the Nonclinical Study Managers which will help to oversee and manage the outsourced nonclinical studies (non-GLP and GLP). In-depth experience with designing, conducting, and evaluating non-GLP and GLP non-clinical studies within toxicology and/or safety pharmacology, preferably with experience with siRNA/oligonucleotides.
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Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders.
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This includes keeping proper GLP lab documentation, authoring technical reports, tech transfer documents and preparing scientific presentations as needed. As a key member of the Manufacturing Sciences – Commercial Manufacturing Support Laboratory group, this individual will be responsible for providing technical and scientific support of upstream, clarification and ultrafiltration processes for commercial production of Biologics, including process and product investigations/troubleshooting, continuous process improvement and life-cycle management, technology transfer and process validation.
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Ensure that CROs follow BMV/GLP/GCP for regulated bioanalyses. Knowledge of BMV guidance, GLP and GCP regulations. Works closely with and provides support to Alexion Global Strategic Sourcing (GSS) and Legal to ensure GLP tox and clinical trial-supporting contracts are in place and in alignment with study plans and protocols while best serving Alexion’s interests.
$167,167 a yearFull-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents, and DEA Regulations is preferred. Demonstrated experience in the field of pharmaceutical packaging or combination product development and commercialization.
$170,500 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago
glp job Company: Pci Services in Billerica, MA
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