Senior Manager, Quality Control Microbiology

Senior Manager, Quality Control Microbiology page is loaded## Senior Manager, Quality Control Microbiologylocations:
El Segundo CA Mariposatime type:
Full time posted on:
Posted 3 Days Agojob requisition :
R2777

Company Overview  Immunity Bio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system.

Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease.

• Immunity Bio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.  
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.  
• Work with a collaborative team with the ability to work across different areas of the company.  
• Ability to join a growing company with professional development opportunities.
** Position Summary
** The Senior Manager, Quality Control Microbiology role provides QC-Micro leadership for Immunity Bio’s early phase (phase I/II) clinical and commercial manufacturing operations at our El Segundo, California, Contract Manufacturing Organizations, Contract Testing Laboratories, and other external collaborators. The Senior Manager for QC-Micro is responsible for overseeing GMP QC Microbiology activities for alliance partner programs supporting clinical and commercial manufacturing operations.

This position is responsible for strategic ownership of the Contamination Control Program at the site(s) in alignment with regulatory expectations and industry best practices with specific areas of responsibility to include, but are not limited to, the governance over CCS element of the environmental monitoring program (EM), the personnel monitoring program (PM), all in-process and release testing (microbiology), all raw materials testing (microbiology), method establishment of microbiological assays, aseptic processing training program, utilities testing program (microbiology), facilities qualification (EMPQ), and cleaning validations.

This position interacts cross-functionally with the Manufacturing, Facilities & Engineering, Regulatory, and Quality Assurance groups to ensure that all manufacturing areas are maintained in a state of control in accordance with applicable regulatory and compliance guidelines.
** Essential Functions
*** Establish, maintain, and oversee support to the contamination control programs for both internal and partner sites.
* Design and oversee Environmental Monitoring programs including Facilities Qualification (EMPQ).
* Design and oversee Utilities Monitoring programs including critical utilities qualification programs.
* Coordinate the execution of Disinfectant Efficacy studies to support Manufacturing Cleaning Program.
* Drive the advancement of the Contamination Control Program in alignment with regulatory expectations and industry best practices.
* Design and maintain Aseptic Process Simulation (Media Fill) Program.
* Oversee external microbiological testing. Standardize and approve methods for raw‑material, in‑process, utility and finished‑product testing (bioburden, sterility, endotoxin, particulate, identification, etc.). Review trend reports and data‑integrity checks.
* Oversee the performance of designated staff.  Responsibilities include interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, and developing and mentoring QC Microbiology teams.
* Responsible for…