- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for internal and external oversight.Manage and/ or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external ... Responsible to design the audit framework globally for Research area, specifically GLP /GCLP studies .Partners with Audit and Compliance QA function to develop… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Laboratory Practice ( GLP ) Regulations. Under the general supervision of the Director , conducts contractual studies or research which is relatively broad in ... scope and which requires decisions as to methodology employed. Looking for a Scientist with interest and/or experience in medical countermeasures (radiation or infectious disease). Plans, conducts and supervises research requiring fundamental scientific… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …to the translational mission of the Center. Role Overview: + Serve as the GLP study director , maintaining a database tracking progress and outstanding ... other agents. As such, the Core provides a major vehicle to facilitate pre-clinical studies , including GLP -compliant safety toxicology studies in support of… more
- Edwards Lifesciences (Irvine, CA)
- …Learn more about BD at bd.com **How you will make an impact:** * Serve as a GLP study director managing in vitro and in vivo biocompatibility safety ... closure of in-house in vitro and in vivo biocompatibility GLP studies including Cytotoxicity (Medium Eluate Method),...look for (Preferred):** * Professional experience as a Sr Study Director or SME Scientist in the… more
- Alaka'ina Foundation Family of Companies (Fort Detrick, MD)
- Microphysiological Systems Associate Study Director Location MD - Fort Detrick Job Code 12054 # of openings 1 Apply Now ... Foundation Family of Companies (FOCs) is looking for a Microphysiological Systems Associate Study Director to support our government customer located in Fort… more
- Colorado State University (Fort Collins, CO)
- …RA II. The Preclinical Surgical Research Laboratory ( PSRL ) is seeking a Study Director position to assist with managing GLP and non- GLP preclinical ... DVM + Previous training and experience managing or coordinating GLP studies . + Previous experience working with...all study -related activities and ensure that all GLP study documentation and procedural practices follow… more
- UTMB Health (Galveston, TX)
- …infectious diseases at BSL3 or higher levels of biocontainment. + Previously served as a Study Director on regulated studies , preferably for FDA Animal Rule ... Director for the Institutional Office of Regulated Nonclinical Studies (ORNcS), study sponsors and/or funding agencies...and/or funding agencies to design and execute regulated nonclinical studies compliant with the US FDA GLP … more
- AbbVie (North Chicago, IL)
- …GLP and GLP toxicology studies , acting to support the Study Director and regulatory infrastructure. MAJOR RESPONSIBILITIES: + Draft study plans, ... study personnel + Coordinate the archival of study data and specimens + Support GLP ...key tasks in the set-up and conduct of nonclinical studies + Support the Study Director… more
- HistoWiz (Long Island City, NY)
- …training files, master schedule, etc. + Lead internal audits in support of GLP studies , writing inspection reports, following up on observations, ensure timely ... customers' growing histology needs. Who are you? The Senior Manager/ Director of Quality is responsible for overseeing the quality...taken on any findings. + Prepare QA statements for GLP study reports. + Prepare laboratory and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and external oversight. + Manage and/ or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external ... Responsible to design the audit framework globally for Research area, specifically GLP /GCLP studies . + Partners with Audit and Compliance QA function to develop… more
- Charles River Laboratories (Ashland, OH)
- …involved in the conduct, direction, and execution of Bioanalytical Chemistry studies . Provide scientific direction, oversight, and guidance to staff. Maintain and ... processes and procedures to provide high quality standards of study design and timely reporting. Contribute to new business...* Ensure departmental policies, practices and procedures adhere to GLP /FDA regulations as they relate to the conduct of… more
- Boehringer Ingelheim (Fulton, MO)
- …laboratory studies as necessary (GCP) + Acts as Test Facility Manager for GLP studies run at the site + Responsible for supporting and providing resources ... site and also in compliance matters related to certain studies conducted in the facility ( GLP -...for existing products. + Experience in protocol development and study design, data management and processing, analysis and collation… more
- Boehringer Ingelheim (Colbert, GA)
- …regarding operations of the Colbert site and in compliance matters related to certain studies conducted in the facility ( GLP - Test Facility Management). + ... **Description** The role of Director , Georgia Clinical R&D Center is a key...and administrative staff) responsible for designing and conducting clinical studies required in Animal Health Research and Development. The… more
- OnKure, Inc. (Boulder, CO)
- …Propose and justify specifications for drug substance and drug product Design and manage GLP and GMP stability studies to justify material use periods and ... Summary: We are seeking a highly motivated and experienced Director of Analytical Chemistry (Drug Substance and Drug Product)...to Good Manufacturing Practices (GMP) and Good Laboratory Practices ( GLP ). This is a highly visible and strategic role… more
- Battelle Memorial Institute (Columbus, OH)
- …the development while maintaining quality and compliance. The Toxicologist functions as a study director within the organization and has oversight of the ... is contingent upon award of work._** **Responsibilities** + Serves as Study Director on toxicology, biodistribution, pharmacokinetic, efficacy, and related… more
- Takeda Pharmaceuticals (Boston, MA)
- …execution and compliance to Takeda standards and global Good Laboratory Practice ( GLP ) regulations [e.g., 21 CFR Part 58; OECD (Organization for Economic ... Co-operation & Development) Principles of GLP ]. + Leverage a comprehensive understanding of archival requirements/best...Takeda:** + Minimum requirements: + Bachelor's degree in Archival Studies , Library Sciences, or similar + 8+ years of… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , Bioanalysis - 2406211500W **Description** Johnson and Johnson is currently seeking an Associate Director , Compliance, located in Springhouse, ... their potential. At Johnson & Johnson, we all belong. As an Associate Director of Compliance in Bioanalytical Discovery and Development Sciences (BDDS), you will… more
- Battelle Memorial Institute (Columbus, OH)
- …Toxicologist functions as a subject matter expert within the organization and, as a study director , has oversight of the scientific elements of projects to ... findings, are accurately recorded and verified. + Identifies and incorporates exceptions to GLP conduct into GLP study Observes appropriate safety and… more
- Frontier Medicines (South San Francisco, CA)
- …Management of drug substance process chemistry development, scale up, and manufacturing for GLP studies and GMP manufacturing at CDMOs + Develop manufacturing ... Frontier Medicines is seeking a highly motivated individual for a newly created Director /Senior Director role in Process Chemistry in Frontier's South San… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Associate Director of Drug Metabolism and Pharmacokinetics is responsible for outsourcing, oversight and monitoring of Drug Metabolism and ... oversight of outsourced work packages in support of approximately 60 clinical studies in which deliverables are monitored and met to achieve portfolio objectives.… more
