ImmunityBio, Inc. · 1 day ago
Senior Manager, Quality Control Microbiology
El Segundo, CA
Full-time
Onsite
Senior Level
$160K/yr - $178K/yr
5+ years expImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing innovative therapies to enhance the human immune system in the fight against cancer. The Senior Manager, Quality Control Microbiology role involves overseeing QC Microbiology activities for clinical and commercial manufacturing, ensuring compliance with regulatory standards and best practices in contamination control.
Health CareHealth DiagnosticsTherapeutics
Responsibilities
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 microbiology and sterility control data review and authorization for external CMOs and CTLs
Verify that partner data (batch records, test results, validation reports) meet the company’s data‑integrity standards
Lead or approve investigations of microbiology‑related deviations, OOS results and EM excursions
Provide subject matter expertise on Microbiology testing, method and process validation, and regulatory compliance requirements
Ensure timely escalation of all facilities (internal and external), utilities and product related microbial issues
Ensure QC Microbiology decisions align with Quality System, GMP and regulatory requirements
Track and trend all facility, utilities, personnel, and product related microbiology data across all product platforms
Maintain Microbiology Laboratory in a state of control, compliance, and inspection readiness. Interface with all auditors (internal and external) to ensure positive audit outcomes
Interface with other departments (e.g., Manufacturing, Facilities, Engineering, QA and Regulatory) to ensure achievement of Immunity Bio’s goals
Create, edit and adhere to Standard Operating Procedures (SOPs)
Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities
Qualification
Required
Bachelor's degree in microbiology or biology, with a minimum of 8+ years of microbiology/sterility control at the management level required; or
Master's Degree in microbiology or biology, with a minimum of 5+ years of microbiology/sterility control at the management level required
Experience in aseptic manufacturing operations within a GMP regulated Biologics or Pharmaceutical environment required
Deep knowledge of microbiology, aseptic processing, and facilities control (environmental monitoring, personnel monitoring, utilities monitoring)
Experience with the simultaneous management of multiple products through early phase clinical trials
Experience qualifying GMP manufacturing facilities (EMPQ, utilities qualification and validation)
Experience hiring, training, and leading cross functional teams
Experience managing Contract Testing Laboratories
Strong technical writing skills with experience preparing: SOPs, analytical tests reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings
Experience with statistical analysis software (SAS, JMP, PRISM, excel etc.). Strong problem-solving skills with demonstrated attention to detail
Demonstrated knowledge and understanding of 21 CFR 210/211, USP, EP and ICH guidelines
Preferred
Experience with a start-up pharmaceutical company is preferred
Benefits
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
Healthcare and Dependent Care Flexible Spending Accounts
401(k) Retirement Plan with Company Match
529 Education Savings Program
Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
Paid Time Off (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
Company
ImmunityBio, Inc.
ImmunityBio, Inc.
501-1000 employees
H1B Sponsorship
ImmunityBio, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (4)
2023 (6)
2022 (7)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.36BKey Investors
Oberland CapitalNantCapitalPatrick Soon-Shiong
2025-07-25Post Ipo Equity· $80M
2025-04-08Post Ipo Equity· $75M
2024-12-11Post Ipo Equity· $100M
Leadership Team
Enrique Diloné
Chief Technology Officer
Leonard Sender
COO
Recent News
Los Angeles Business Journal
2025-12-24
Company data provided by crunchbase