- Amgen (Thousand Oaks, CA)
- …lives of patients while transforming your career. **Senior Manager Manufacturing Systems ( Drug Substance Automation)** **What you will do** Let's do this! Let's ... operational support and maintaining automation systems for the GMP Clinical and Commercial Drug Substance Plant Operations at Amgen Thousand Oaks (ATO). This role is… more
- Gilead Sciences, Inc. (Foster City, CA)
- …responsibility of this position is to lead biotransformation activities in the Drug Metabolism Department and in collaboration with the Clinical group. The scientist ... compounds in vitro and in vivo to understand metabolic pathways to support drug discovery and development. More broadly, the scientist is expected to integrate this… more
- Amgen (Thousand Oaks, CA)
- …of patients while transforming your career. **Process Development Senior Scientist - Drug Substance Technologies - Synthetics (DSTS)** **What you will do** Let's do ... currently seeking a talented Process Development Senior Scientist to join our Drug Substance Technologies - Synthetics (DSTS) group. Amgen's DSTS group within… more
- Kelly Services (Thousand Oaks, CA)
- Research/ Sr Research Associate - CNS Drug Delivery **Job Summary:** Our client, an innovative neuroscience company at the forefront of biotechnology, is focused on ... **Senior Research Associate** to support bioanalytical and in vivo studies in CNS drug delivery. This role will be pivotal in advancing the research and development… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Lead the DMPK strategy for programs at various stages of drug discovery/development in collaboration with inter-disciplinary team; champion activities to deliver ... + Interpretation and strategy for evaluating the impact of anti- drug antibody (ADA). + Participate in business development and...quality and timely delivery of written PK reports and regulatory documents (IND, IMPD, IB, BLA) for regulatory… more
- Stanford Health Care (Palo Alto, CA)
- …with policies. + Prepares, packages, compounds and labels non-sterile drug products with appropriate final pharmacist checks. **Education Qualifications** + ... + Knowledge of influence of patient's age, sex, concomitant disease states, concurrent drug therapy, foods and diagnostic procedures on drug activity and… more
- Amgen (Thousand Oaks, CA)
- …oversight of operational activities associated with and supporting the aseptic Drug Product manufacturing areas at Amgen, Thousand Oaks. Under general supervision, ... Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations. + Perform impact assessments as part of change controls… more
- AbbVie (South San Francisco, CA)
- …process performance and 2) develop robust, phase-appropriate cell culture processes for drug substance GMP production to enable human clinical studies and eventual ... and review technical reports, GMP campaign summary reports and relevant sections in regulatory filings + Actively seek out opportunities to optimize our platform or… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. + ... Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory , Process Development, Analytical Development, and CDMO technical teams. + Stay current with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …presentation/publication. Comfortable working with and educating colleagues in drug metabolism, toxicology and clinical pharmacology departments, on strategies ... to understand drug metabolism and disposition. Demonstrates excellent scientific verbal and...written to communicate clear messages and are ready for regulatory submissions. State of the art bioanalysis by LC/MS,… more