Analytical and Microbiology Quality Manager

Analytical and Microbiology Quality Manager page is loaded## Analytical and Microbiology Quality Manager locations:
Torrey Pines, CAtime type:
Full time posted on:
Posted 3 Days Agojob requisition :
R2803

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 Analytical and Microbiology Quality Assurance (AMQA) organization provides phase-appropriate, global quality assurance to the Quality Control group (QC).  As microbiology and analytical QA Subject Matter Experts (SMEs), AMQA collaborates with the QC team in all aspects related to the development, verification, qualification, validation, transfer and optimization of analytical and microbiology test methods used for internal and external product testing.

AMQA supports qualification and release of reference standards, internal and external stability testing, supports regulatory filings including INDs and BLAs, and reviews/approves all QC GMP records including SOPs, Certificates of Analysis, deviations, change controls, CAPAs, internal findings and laboratory investigations.

The Analytical and Microbiology Quality Manager provides quality oversight and approval of GMP laboratory operations supporting microbiological and analytical testing performed both in-house and at external contract testing organizations (CMOs/CTOs). This role ensures that laboratory activities supporting development characterization and product release are conducted in accordance with applicable quality standards and that data generated are reliable, accurate, and suitable for regulatory and commercial decision-making.

The position will serve as a quality partner to QC, Product Development, Process Sciences and external testing laboratories, while maintaining independent QA authority.
** Essential Functions
*** Provide QA oversight of microbiology and analytical assays performed at in-house and external GMP QC laboratories.
* Review and approve laboratory data and documentation related to microbiological testing, environmental monitoring, and analytical assays.
* Review and approve environmental monitoring results, trends, and excursions for laboratory and biosafety cabinet environments.
* Provide QA oversight for analytical testing supporting product development, characterization, and product release including internal and external laboratories.
* Review and approve analytical data, reports, and summaries used for:  + Lot release  + Stability  + Assay and product development  + Product comparability or lifecycle activities
* Review and approve investigations, deviations, and CAPAs related to analytical testing, data integrity, contamination events, EM excursions, and assay failures.
* Ensure appropriate quality oversight mechanisms are in place for external testing partners.
* Provide on-site QA support for regulatory inspections and partner audits.
* Furnish quality oversight of the Stability and Reference Standard…