IB Temporary - Senior Associate QCA

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 IB Temporary - Senior Associate in the Quality Control department is responsible for supporting late-stage analytical method validation and regulatory submissions for cell therapy programs. This role is responsible for generating, and organizing high-quality GxP documentation to supports QC method readiness and regulatory submission for clinical and commercial manufacturing. This role will interact cross-functionally with members of the Quality Assurance, Analytical Development, Regulatory CMC, and Manufacturing.  

 Essential Functions

• Support QC analytical documentation by drafting and reviewing method validation and transfer protocols and reports to support late-stage and commercial programs
• Support regulatory document authoring and review by compiling analytical method data, drafting sections related to analytical methods to ensure alignment with regulatory expectations
• Manage and execute change controls and deviations in accordance with quality system requirements
• Perform statistical data analysis to support method feasibility/validation
• Collaborate cross-functionally with Analytical Development, Quality Assurance, and Regulatory Affairs to collect data, and ensure documentation accuracy and scientific clarity.
• Ensure compliance with GxP and internal quality systems, including document formatting, version control, routing, archival, and adherence to established documentation standards.
• Prepare documentation packages for supporting data requests, and ensure QC analytical records are complete, organized, and inspection ready
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor’s degree in a life sciences discipline with 3+ years of relevant experience required
• Experience with analytical methods, including but not limited to flow cytometry, qPCR, ELISA and cell-based assays required
• Proficient in data analysis, statistical tools, and interpretation of analytical results required
• Experience working within GMP/GxP environments, including documentation, change control process and quality systems preferred
• Experience with the technical transfer and qualification/validation of analytical assays preferred

Knowledge, Skills, & Abilities

• Strong written and verbal communication skills including technical writing skills
• Ability to multitask across multiple functional areas, and is timeline focused
• Able to proactively take initiative to remove roadblocks that interfere with the completion of assigned tasks and has flexibility in their work schedule in order to meet the demands of a multi-product clinical phase biopharmaceutical company.
• Solid understanding of analytical methods, data analysis for statistical evaluation and visualization
• Ability to work cross-functionally in a fast-paced, regulated environment
• Strong documentation skills with attention to detail and accuracy
• Organizational skills with ability to prioritize multiple tasks
• Ability to manage change controls and maintain compliance with procedures
• Solid knowledge of GMP/GxP requirements and quality systems
• Ability to perform statistical analysis
• Proficiency in Microsoft Word, Project, and Excel
• Excellent communication and collaboration skills across cross-functional teams
• Strong technical writing skills with experience preparing: SOPs, analytical tests reports, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.
• Strong problem-solving skills with demonstrated attention to detail.
• A demonstrated knowledge and understanding of 21 CFR 210/211, USP, EP and ICH guidelines.

Working Environment / Physical Environment

• The position works on site.
• Regular work schedule is Monday – Friday, within standard business hours. 
• The position requires flexibility in working schedule, i.e., occasional off-hours, second shift, and weekends.  Will require occasional weekend and holiday work to meet business needs.
• Exposure to onsite in-lab environment.
• Ability to gown and gain entry to manufacturing areas and be in the cleanroom environment for extended periods of time.

The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

$38.70 (entry-level qualifications) to $43.00 (highly experienced) per hour

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.