- Sanofi Group (Swiftwater, PA)
- …medical device industry experience + Experience in Medical Devices and/ or Drug Device Combination product development (eg ISO11608, ISO10993, ISO60601, ... Contact (SPOC) for manufacturing sites of medical devices or combination products for device related Change Controls...of medical devices or combination products for device related Change Controls topics. **Provide mentoring support to… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …Skills: **Required:** + 6+ years of Quality Assurance experience in the Pharmaceutical ( Drug /Biologics), Drug Device Combination Product and/or Medical ... specified QA/GMP compliance regulations, ie: 21 CFR Part 210/211, 600, 820, Drug / Device Combination products. + As required participates in compliance… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …of biologic/small molecule drug substances, drug products, and drug - device combination products. + Determine regulatory and scientific/technical ... post-approval, including biologic upstream and downstream processes, analytical methods, and drug / device combination products. + Comprehensive knowledge and… more
- Cordis (Irvine, CA)
- …Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of ... and training abilities to promote a compliance culture. + PMA level combination device experience preferred. + Certification in Quality Management (eg, CQE, CQA,… more
- J&J Family of Companies (West Chester, PA)
- …advanced biomaterials such as ceramic bone void fillers, bioabsorbable polymer implants, drug - device combination products, and cell-based therapies. We ... engage in early stage evaluation of new materials technologies, device design and development, manufacturing process development, and support of preclinical testing… more
- Vera Therapeutics (Brisbane, CA)
- …have a strong background in drug delivery systems, medical device and combination product regulations. Exceptional organizational, clear communication, and ... main contact for all quality-related inquiries and issues concerning device and combination product * Collaborate with...* 8 years of experience in quality oversight of drug product device development, with a proven… more
- Lilly (Indianapolis, IN)
- …of Raw Materials, Drug Substance, Drug Product, and/or Drug - Device Combination Products. **Additional Skills/Preferences:** + Proven ability to ... Records and electronic review and disposition processes across materials, drug substance, drug product, device assembly, and packaging. + Experience… more
- Cordis (Irvine, CA)
- …Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of ... with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that manufacturing processes adhere to these regulations.… more
- AbbVie (Boston, MA)
- …(AE) is responsible for maximizing business opportunities with approved on-market products ( drug device combination ) for the Parkinson's Franchise. The ... credentialing requirements may include, but not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases. + Represent… more
- Lilly (Concord, NC)
- …up. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug / device combination products through effective ... Lilly is designing and building a new state of the art Parenteral, Device , and Packaging Assembly Facility in Concord, North Carolina. This is an exciting… more