ImmunityBio, Inc. · 7 hours ago
Analytical and Microbiology Quality Manager
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$141K/yr - $155K/yr
8+ years expImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing cell and immunotherapy products to enhance the natural immune system's ability to combat cancer. The Analytical and Microbiology Quality Manager oversees quality assurance for microbiological and analytical testing, ensuring compliance with quality standards and regulatory requirements while collaborating with various teams within the company.
Health CareHealth DiagnosticsTherapeutics
Responsibilities
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 program
Ensure data integrity principles are applied consistently across microbiology, and analytical testing activities
Evaluate the suitability of laboratory data for use in regulatory submissions and batch disposition decisions
Support preparation and approval of responses to observations related to microbiology and analytical testing
Provide subject matter expertise for laboratory compliance during inspections
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 a life-sciences or engineering discipline with 10+ years of progressive experience in a GMP regulated cell therapy environment required; or
Advanced degree in a life-sciences or engineering discipline with 8+ years of progressive experience in a GMP regulated cell therapy environment required
Experience with the following QC assays: cell-based assays, HPLC (RP, SEC, IEX), ELISA, SDS-PAGE (reduced and non-reduced), HCP, mycoplasma, sterility, endotoxin, and bioburden required
Experience working under 21 CFR 210/211, ICH guidance applicable to cell therapy and pharmaceutical products, and the United States and European Pharmacopeias required
Experience in Process Validation required
Experience in a commercial phase cell therapy environment required
Proficiency with the following QC assays: cell-based assays, HPLC (RP, SEC, IEX), ELISA, SDS-PAGE (reduced and non-reduced), HCP, mycoplasma, sterility, endotoxin, and bioburden
Strong understanding of GMP requirements for microbiology and analytical QC
Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills
Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
Strong problem solving and analytical skills with demonstrated ability to be detail oriented, while managing multiple projects simultaneously
Ability to influence without authority
Ability to work with a high degree of autonomy
Preferred
Experience in a leadership role successfully managing personnel and projects desirable
Experience in clinical manufacturing is desirable
Experience with contract manufacturing organizations 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
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
Genetic Engineering News
2026-01-23
legacy.thefly.com
2026-01-23
Company data provided by crunchbase