- Parexel (Sacramento, CA)
- …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
- 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
- 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