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Maintain strict compliance with GMP and GLP standards in the lab, championing best practices in every aspect of the formulation process. As a Senior Formulation Chemist, you will be an integral part of the Product Development team at JPMS. Reporting to the EVP of Research & Development, you will focus on formulating innovative hair color, care and styling concepts, lines and reactive products.
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5+ years of obesity-related clinical development activities with GLP-1 agents and a minimum of 15+ years of relevant drug development experience in the pharmaceutical/biotechnology industry, academic and/or medical research environments, including significant experience leading early and late phase clinical development studies, programs and clinical operations with strong understanding of the elements of drug development programs and experience in their design and execution.
$499,400 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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This role ensures that all relevant quality and regulatory requirements are met for good clinical practices (GCP), good laboratory practices (GLP), good pharmacovigilance practices (GVP), and compliance with GxP regulations from the FDA, MHRA, and other applicable regulatory bodies.
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Preclinical (GLP), Clinical (GCP), Patient Safety/Pharmacovigilance (PV), GMP (CMC) Knowledge of regulatory standards across GLP, GCP, PV, and GMP. Preclinical (GLP), Clinical (GCP), Patient Safety/Pharmacovigilance (PV), GMP (CMC.
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Demonstrated experience in design, management, and improvement of global quality management systems (QMS); must have medical device experience; prefer cross GxP (GLP, GCP, GVP, GMP and GDP) and modality experience (medical device, small molecule, cell, gene, biologics, etc.
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A leading organization in the pharmaceutical industry is seeking a Director to lead their Clinical Quality Assurance (CQA) efforts with a strong focus on Good Clinical Practices (GCP) and Good Laboratory Practices (GLP.
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Minimum of 5+ years of progressive Quality experience in a regulated environment, preferably in biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred). This individual will report to the Sr. Director of Global GCP/GLP compliance and will work closely with the US Site VP and the Global Quality team.
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Experience in GLP/GMP environment a plus. Adopts Practical Process Improvement (PPI) methodologies. Experience with receiving dangerous goods a plus. Experience in GLP/GMP environment a plus. Strong attention to detail in daily site safety procedures.
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Lead the development and execution of GLP and non-GLP toxicology study designs; critically review and edit nonclinical toxicology study reports, and coordinate report finalization with CROs.
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GMP or GLP and/or FDA manufactured component experience/knowledge preferred. Mitsubishi Chemical Performance Polymers, Inc. (MCPP) a subsidiary of Mitsubishi Chemical is wholly owned, MCC and its twenty group companies provide products and services to customers in North and South America providing a broad range of businesses including chemical, petrochemical, composite materials, pharmaceuticals, electronics, and other businesses.
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Solid knowledge of CRO, Biotech and Pharma industries with a grasp on bioanalytical, both GLP and non-GLP studies. These positions will support the growth of Frontage global business, including both U.S. and China, by seeking and expanding US biopharma, biotech and institution clients Depending on the experience, the areas of focus include a combination of the following: Medicinal Chemistry, CMC & CDMO, Drug screening & Biology, Pharmacology, DMPK, and Safety & Toxicology.
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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 3 days ago - UpvoteDownvoteShare Job
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Familiarity with GLP, GMP, CLIA, and ISO regulatory guidelines. Enforce GMP/GLP/ISO regulations and standards. Familiarity with GLP, GMP, CLIA, and ISO regulatory guidelines. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at.
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Design and oversee the implementation of quality systems specifically for CMC development activities, including the release of products for GLP and GCP studies. Establish robust processes for the review and release of products intended for GLP and GCP studies, ensuring data integrity and compliance.
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glp job Company: Pci Services in Woburn, MA
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