Manager, QCA Potency Assay & Trending

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

TheQC Manager of Potency and Trending will be assigned responsibilities for the management of laboratory testing activities for release testing/stability testing, critical reagent qualification, assay transfer, routine preventive maintenance, and completing lab administrative duties, including Metrics. The position will be required to oversee and coordinate method troubleshooting and investigations. Test Method, Qualification Protocols, and SOP oversight will also be required, using knowledge of GMP/cGMP practices to incorporate the appropriate regulatory requirements into the methods and procedures. Additionally the position will be responsible to oversee the Continued Process Variation (CPV) trending program.

The position will largely independently oversee a wide variety of complex tasks that support the establishment, and transfer of release methods into the QCA lab.

Essential Functions

• Oversight and scheduling of all Cell based Potency lab testing, development, qualification, investigation, maintenance, and support activities.
• Oversight of the QC Analytical lab staff, including hiring, training functions, 1:1 meetings, and career development for QCA staff.
• Interface as QCA member to interact with other departments to coordinate activities.
• Certificate of Analysis or Results Reporting creation for lot release for all QC testing for DSDP, and Stability Samples
• Reviewing of assay reports in line with commercial GMP standards.
• Backup analyst for completing assays.
• Create and maintain metrics for assay performance and lab operations.
• Ownership / Supporting Ownership of the CPV program for the trending of drug product for different programs
• Participate and coordinate method development, optimization, transfer, and qualification work (protocol drafting, data collection, and report writing).
• SOP and Test Method drafting and revisions.
• Complete OOS reports including corrective and preventive actions independently.
• Ensure quality control staff, equipment, and procedures are compliant to regulatory guidelines and data integrity principles are adhered to.
• Performs other projects and duties as assigned.

Education & Experience

• Bachelor's degree in Cell Biology or Immunology or related discipline with 8+ years' of relevant experience in the biotechnology industry with emphasis in quality control testing required; OR
• Master's degree in Biology or related discipline with 6+ years of relevant experience in the biotechnology industry with emphasis in quality control testing
• Demonstrated understanding of QC testing requirements, methodology and equipment such as Cell Culture, Cell Counters, Plate Readers, Flow Cytometry required
• Experience in leading teams in a GMP environment.
• Demonstrated self and team adaptability under changing circumstances to deliver results.

Knowledge, Skills, & Abilities

• Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics
• Knowledge of MS Word, PowerPoint, and Excel
• Ability to work independently and within cross-functional teams to deliver on project timelines and department goals.

Working Environment / Physical Environment

• Must work on-site in a lab environment
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Lift and carry materials weighing up to 20 pounds
• Flexibility in working schedule, i.e., off-hours, second shift, and weekends.

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.

$140,000 (entry-level qualifications) to $155,000 (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.

ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.