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The QAU will support the comparable GMP production activities related to GLP toxicology lot production and technical transfer activities as it relates to clinical batch release testing conducted at GTP to support the clinical CMO. The QAU will also provide Quality Assurance support to the research-based portion of the GTP, in terms of SOP management, training, document management and archiving, and audit support.
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Located in the suburbs of Boston & Cambridge, they are seeking an experienced Process Chemistry leader to design, execute, and lead chemical process development and manufacturing strategy to produce drug substances for GLP toxicology, clinical supplies and potential commercialization.
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This is a dynamic role participating in the advancement of preclinical research into the clinic, with particular focus on the execution of exploratory, pilot, and pivotal (GLP) toxicology studies.
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Contributes to toxicology studies and/or program development through study monitoring of outsourced non-GLP and GLP studies and other activities as assigned by his/her supervisor.
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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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This role will also support initiation and monitoring of GLP impurity qualification and preclinical safety studies conducted at external contract research labs. Demonstrated experience with GLP preclinical safety study execution and oversight is highly desired.
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Lead and/or manage the design, monitoring, and interpretation of In Vitro, In Vivo, or pre-clinical bio-compatibility studies conducted under Good Laboratory Practices (GLP). Interpreting the results of Biological/Volatile Organic Compound tests for impacts to patient safety and preparation of expert reports on toxicology/patient risk in the support of regulatory documentation.
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The candidate should possess an in-depth understanding of safety pharmacology, investigative and regulatory toxicology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
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Oversee and provide strategic direction for Toxicology/Pathology, BioAnalytical/DMPK, Biomarkers, and Clinical Pharmacology teams to ensure robust support for clinical development programs. 12+ years of experience in the biopharma industry in non-clinical development (toxicology, pharmacology, pharmacokinetics, bioanalytical sciences, or related discipline.
$265,000 - $300,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Responsible for directing, coordinating, creating, and evaluating the activities of the Quality Department across Drug Manufacturing (GMP), Clinical Research & Development (GCP), and Pharmacology & Toxicology (GLP) functional activities.
$260,000 - $360,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Conceptualizes, develops, revises, and finalizes toxicology (GLP and non-GLP) study designs and reports; drafts nonclinical sections for IND/CTA and NDA/BLA submissions and other regulatory documents (e.g., to ensure regulatory compliance.
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Minimum of a bachelor’s degree in the field of biology, toxicology, animal science or other relevant field with at least 2 years relevant experience. Responsible for the supervision of technical and scientific conduct of studies according to GLP regulations and related protocol.
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DVM/PhD or PhD in biology, toxicology or related field, Board certification in toxicology is highly desirable. Lead issue-resolution teams, driving the science for investigative and discovery toxicology as needed.
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As the Senior Scientist & Study Director, you'll provide pivotal oversight for in-vivo studies focused on cell and gene therapy, particularly in areas like Toxicology, BioDistribution, B-Cells, T-Cells, Oncology, and the Central Nervous System, primarily with immunocompromised mouse models.
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Responsible for GLP and non-GLP genetic toxicology study design, interpretation and project science within this area of expertise on one or more project teams. This role reviews and provides input to genetic toxicology strategies and independently proposes, designs and interprets non-GLP and GLP genetic toxicology studies in support of issue resolution and/or drug submissions to regulatory agencies.
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