Senior Specialist, Analytical & Microbiology QA

Company Overview
ImmunityBio, 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.
Why ImmunityBio?
• ImmunityBio 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 QA Specialist, Analytical and Microbiology QA, provides Quality Assurance oversight for microbiology and analytical Quality Control (QC) laboratories, ensuring compliance with GxP, regulatory expectations, and company Quality Systems. The role supports review, approval, and QA governance of QC methods, laboratory records, equipment qualification, environmental monitoring programs, and complex QC assays including but not limited to HPLC, ELISA, PCR, mycoplasma, sterility, bioburden, environmental monitoring, CTLL2 potency assays, and other cell based or molecular assays.

This position collaborates closely with QC and other cross functional groups to ensure data integrity, investigation quality, audit readiness, and robust quality risk management across microbiology and analytical operations.

Essential Functions

• Review and/or approve executed quality control methods, reports, equipment documentation and analytical testing data for accuracy, completeness, good documentation practices, and compliance to cGMP; Document, manage and support issue resolution associated with document review and/or approval
• Provide QA oversight for microbiology and analytical QC operations, including mycoplasma, sterility, bioburden, endotoxin, HPLC, ELISA, PCR, CTLL‑2, and EM programs. Support QC microbiology and analytical laboratory workflows to ensure testing is performed per approved procedures and regulatory expectations. Own, Lead and/or manage quality programs supporting Microbiology and Analytical QA activities.
• Support QC laboratory investigations linked to contamination events, control failures, invalid assays, invalid SSTs, OOTs and OOS.
• Initiate and/or approve deviations and conduct robust investigations related to microbial excursions, EM action-level events, and data integrity concerns.
• Initiate and own  Change Controls, complete associated implementation task assignments and provide supporting documentation for completion of change records.
• Maintain QA oversight of the IB QC laboratories to ensure inspection readiness and continuous improvement Identify continuous improvement activities and implement changes to enhance the overall quality systems, procedures and oversight of product quality and quality control laboratories
• Support preparation for internal and external audits as well as regulatory agency inspections, and participate as a subject matter expert
• Maintain compliance with all assigned training requirements, develop QA training programs/curricula and train others as assigned
• Create, draft and/or revise SOPs, work instructions, and other controlled document types
• Lead collaborative cross-functional team meetings to resolve quality issues
• Provide mentorship cross-functionally for investigating non-conformances to procedures, processes, and specifications
• Perform ad-hoc and cross-functional QA duties and/or projects, as assigned, to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor’s degree in a life-sciences or engineering discipline with 7+ years of experience in the pharmaceutical / biopharmaceutical industry is required
• 4+ years of direct experience in Quality Assurance / Quality Control is required
• Experience with biologics cGMP manufacturing, ideally recombinant protein and cell therapy cGMP manufacturing required
• Experience in supporting both internal and external regulatory inspections (i.e. FDA, EU) required 
• Experience  working with quality management systems required
   

Knowledge, Skills, & Abilities

• Understanding of quality management systems
• Advanced understanding of quality management systems
• Good knowledge of biologics cGMP manufacturing and cell therapy cGMP manufacturing
• Strong verbal, written, and interpersonal communication skills
• Proficiency in computer use and Microsoft Office applications
• Proven ability to work independently and analyze and resolve issues that impact quality
• Attention to detail with strong analytical and problem-solving skills
• Performing work that consistently requires independent decision-making and the exercise of independent judgment and discretion. 

Working Environment / Physical Environment

• This position works on site in Culver City, CA
• Regular work schedule is Monday – Friday, within standard business hours. 
• Flexibility in working schedule, i.e., off hours, second shift, weekend and travel work as required
• Must be able to gown under laboratory conditions. 
• This position will be exposed to pharmaceutical production environments and requires the ability to gown and gain entry to manufacturing areas.

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

$117,000 (entry-level qualifications) to $128,700 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • 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.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.