- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Process Development, Downstream Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... for patients suffering from immunological diseases. Position Summary: The Senior Manager , Process Development, Downstream will be responsible for all aspects of… more
- Fujifilm (Thousand Oaks, CA)
- …culture that will fuel your passion, energy and drive - what we call Genki. The Manager Quality Control Analytical will manage a group of Quality Control ... and approve laboratory procedures, protocols and reports. + Support cGMP manufacture and supply of high- quality cell...outcomes. + Experience in analytical method qualification, transfer, and validation + Experience in cGMP cell therapy… more
- Amgen (Thousand Oaks, CA)
- …Join us and transform the lives of patients while transforming your career. Maintenance Manager **What you will do** Let's do this! Let's change the world! This role ... within the Manufacturing Clinical Supply (MCS) organization at Amgen. The Maintenance Manager - will be responsible for leading maintenance teams, ensuring reliable… more
- Fujifilm (Thousand Oaks, CA)
- **Position Overview** The Sr. Manager Quality Control (QC) Microbiology at Fujifilm Diosynth Biotechnologies California (FDBC) requires both leadership, ... to enable QC to complete department objectives. The Sr. Manager is responsible for ownership of FDBC Environmental Monitoring...and on the floor laboratory oversight support. + Support cGMP manufacture, testing, and supply of high- quality … more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted supply of ... global external contract manufacturing network, while ensuring compliance with cGMP , regulatory requirements, and environmental, health, and safety legislations.… more
- BeOne Medicines (Emeryville, CA)
- …at designated Contract Manufacturing Organizations. This includes working with CMO Quality as a QC representative to review and approve technical documents ... serving as analytical/QC SME in the areas of method qualification/ validation /transfer, specification development and management, stability studies, shelf-life updates… more
- Fujifilm (Santa Ana, CA)
- …be required to perform other duties as assigned or as needed by Validation Manager . **Required Skills/Education** + BS in Bioengineering, Chemical Engineering, ... . + Advanced knowledge of equipment/system/facility qualification. + Knowledge of FDA/ cGMP /QSR and associated guidelines relevant to validation . **Salary and… more
- Kelly Services (Carlsbad, CA)
- …a consistent schedule. Exceptions to the schedule must be approved by the manager in advance. **Overview** This client is an industry-leading company that's leading ... the way in high- quality analytical testing services. As a Microbiologist, you will...all activities are performed within an appropriate level of cGMP compliance. Previous experience with aseptic filling operations and… more
- Eurofins (San Ramon, CA)
- …the function of the laboratory + Conduct timely investigations in coordination with Quality Assurance related to site quality events, including, but not limited ... duties in compliance with all applicable regulatory and accrediting agencies and cGMP expectations, including but not limited to: Facility and equipment maintenance,… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- … Documentation. This is an on site position and you will report to the Quality Systems Manager . **How you will contribute:** + Support Change Control, Deviation, ... including nonconformance management, change control, document control, product release, supplier quality . + General knowledge of cGMP manufacturing and… more