- Parexel (Indianapolis, IN)
- …aspects of laboratory equipment during audits + Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures **Required Skills and ... standard operating procedures (SOPs) **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with… more
- Covenant Health Inc. (Crossville, TN)
- …seriously ill patients, advanced medical and surgical care is provided at CMC including telemetry monitored beds and an intensive care unit. Additionally, Cumberland ... record. + Completes Quality Control procedures and documentation required by regulatory agencies, medical center and department policy. + Maintains all equipment… more
- Gilead Sciences, Inc. (Foster City, CA)
- …translational science, biomarker strategy, and early clinical trial design. + Regulatory knowledge: Familiarity with FDA/EMA guidance for preclinical and early ... clinical phases. + CMC awareness: Understanding of drug substance/product development and manufacturing timelines. + Possess strong business acumen to align drug… more
- Sanofi Group (Waltham, MA)
- …in helping our teams accelerate progress. The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment of best-in-class manufacturing ... sites, overseeing process scaling up, defining scale down models, and associated regulatory filing activities. We are looking for a candidate with excellent… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and verbal) skills. The ideal candidate would also have: + Experience with CMC requirements for drug development and manufacturing of a range of product modalities. ... the biopharmaceutical industry, R&D, and product commercialization, including the regulatory framework, and of global biopharmaceutical manufacturing sector and… more
- Lilly (Indianapolis, IN)
- …Safety, Environmental and Quality Team members, Purification Development colleagues, CMC Team members, Discovery team members, Analytical Services, Tech ... Service/Manufacturing Science representatives, Operations, Engineering, Regulatory and Maintenance personnel. Especially important, in this role, is that you adhere… more
- RWJBarnabas Health (Toms River, NJ)
- …37 West, Toms River, NJ 08755 Job Title: Administrative Director Location: CMC Support Department Name: Administration Req #: 0000225098 Status: Salaried Shift: Day ... OBGYN, reproductive medicine, and urogynecologist + Oversight of quality and regulatory compliance in collaboration with clinical leadership and quality management… more
- RTX Corporation (Forest, MS)
- …States of America **Location:** MS301: 19859 Highway 80, Forest 19859 Highway 80 CMC Forest, Forest, MS, 39074 USA **Position Role Type:** Onsite **U.S. Citizen, US ... to Raytheon Airborne Systems to ensure compliance with contractual, company, and regulatory requirements. This position will provide education and knowledge on the… more