- IQVIA (Durham, NC)
- …to drive quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions. Serve as a resource for the ... methodology development work with regards to statistical standards and validation procedures. - Consult on operational/statistical/therapeutic area topics. **Knowledge… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …and project standards. The evaluation and development of study requirements and validation plan are also in the scope of this position. Works independently ... datasets utilizing Regeneron tools and methodologies. * Support creation and validation of submission requirements (ie annotated CRF, data export files, define… more
- Lilly (Indianapolis, IN)
- …+ Provide technical oversight of third-party organizations throughout the transfer, validation and implementation of immunogenicity and biomarker assays used in ... PhD degree in a scientific area (eg, immunology, biochemistry, pharmaceutical sciences) with 0-3 years of post-graduate experience. **Additional Preferences**… more
- Lilly (Indianapolis, IN)
- …years of experience in clinical data management, database programming or system validation experience in the clinical, pharmaceutical , biotech, CRO or regulatory ... and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. **This is a hybrid… more
- Charles River Laboratories (Reno, NV)
- …+ Provide anesthesia support to non-surgical studies. + Perform weekly spore validation of autoclave. + Maintain equipment maintenance logs and make arrangements for ... equipment in need of calibration, validation , and/or repair. + Record keeping of Standard Operating procedures (SOP's) and Business Operating Procedures (BOP'S)… more
- Takeda Pharmaceuticals (Boston, MA)
- …implement _in vitro_ screening cascades, conduct high-throughput screening and hit validation , perform SAR screenings for hit/lead optimization, and analyze hit/lead ... with 10+ years of relevant experience in pharma + Experience in the pharmaceutical industry with a demonstrated track record of supporting cross-functional teams to… more
- Lauridsen Group Inc. (Ankeny, IA)
- …in manufacturing efficiency and productivity through process optimization, equipment validation , data analysis, and innovation. Lead projects supporting new product ... or process engineering role + Experience with process optimization, equipment validation (IQ/OQ/PQ), and technical transfers. + Familiarity with process control… more
- Fortive Corporation (Irvine, CA)
- …technical documentation, including engineering drawings, design specifications, SOPs, and validation protocols. Apply FBS (Fortive Business System) tools and lean ... a mechanical engineering role, preferably within a medical device, pharmaceutical , or GMP-regulated environment. Proficient in CAD software (SolidWorks preferred),… more
- Lilly (Indianapolis, IN)
- …support for Quality Control activities + Experience on equipment qualification, system validation and process validation . + Thorough technical understanding of ... quality systems and regulatory requirements. + Knowledge of pharmaceutical manufacturing operations. + Demonstrated coaching and mentoring skills. + Experience in… more
- Contract Pharmacal Corp (Hauppauge, NY)
- …of commercial materials (raw materials, finished product release, stability, validation , investigation), and environmental samples, as assigned, and documenting ... investigations, as assigned. + Assist in Cleaning, Method and Process validation testing and protocol/report review, as assigned. + Suggest improvements to… more