- Amgen (Thousand Oaks, CA)
- …the lives of patients while transforming your career. **Senior Manager Manufacturing Systems ( Drug Substance Automation)** **What you will do** Let's do this! ... support and maintaining automation systems for the GMP Clinical and Commercial Drug Substance Plant Operations at Amgen Thousand Oaks (ATO). This role is… more
- Amgen (Thousand Oaks, CA)
- …lives of patients while transforming your career. **Process Development Senior Scientist - Drug Substance Technologies - Synthetics (DSTS)** **What you will do** ... seeking a talented Process Development Senior Scientist to join our Drug Substance Technologies - Synthetics (DSTS) group. Amgen's DSTS group within Process… 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 ... and CMC cell culture program deliverables and help drive drugs substance cell culture development strategy though program lead assignments in cross-functional… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …the Manufacturing Sciences (MS) Department specifically in Cell Culture and Purification ( Drug Substance ) manufacturing processes. This role is responsible for ... MS day to day manufacturing support, inter-facility, and global process alignments/improvements initiatives of commercial and clinical manufacturing operations of a multi-product manufacturing plant. This position directly supports manufacturing operation… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …**** The Associate Director, MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes for the company's ... biologics portfolio executed at CDMOs. This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle… more
- US Marine Corps (Twentynine Palms, CA)
- …clinical experience post independent licensure. Required Certification: Must achieve certified substance abuse counselor (Alcohol and Drug Counselor II, ... and effectively. Responsibilities Incumbent serves as the clinical counselor for the Substance Abuse Counseling Center (SACC), Substance Abuse Program (SAP),… more
- Merck (San Francisco, CA)
- …of DSCS Digital initiatives. Development Sciences and Clinical Supply (DSCS) enables Drug Substance , Drug Product, Analytical Development, and Clinical ... complex problems. Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to agency information requests, the Notified Body Option). + Provide oversight for changes to drug substance and drug product CMC details. + Accountable for ... Expert with Quality representatives at CXO(s) and Gilead Sites. + Support drug substance and drug product technology transfer, and new product launches.… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug product at CDMOs + Design and ... lead method validation and implementation activities for drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines +… more
- Amgen (Thousand Oaks, CA)
- …In this vital role you will be part of Amgen's Process Development organization, Drug Substance Technologies - Synthetics (DSTS) plays a vital role in developing ... robust drug substance manufacturing processes to serve patients. Specifically, DSTS is an integrated organization of small molecule process chemists and… more