Associate, Quality Control Analytical

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 Associate, Quality Control Analytical (QCA) is responsible for ensuring the timely execution of QCA assays in support of product release across all of ImmunityBio's oncology product platforms. This role will interact cross-functionally with members of Quality Assurance (including Product Quality, Quality Engineering, Material Quality, Supplier Quality, Validation, QA Operations, etc), Facilities/Engineering, , and Process Sciences teams.

Essential Functions

• Ensure prompt scheduling, processing and testing of all activities assigned in support of raw materials testing, in-process, release and stability testing to support all products.

• Support the testing of assigned samples to meet turnaround time (TAT) requirements.
• Support method development, method qualification/validation and transfer activities.
• Support GMP Lab Testing Readiness (assays, inventory, equipment ownership, etc.)
• Support new equipment induction and Operational Qualification activities (IQOQ)
• Support the Continued Process Verification (CPV) program for fusion drug products.
• Support product-specific Bill of Materials (BOM) review and phase-appropriate raw material testing strategy (in-house and outsource).
• Adhere to, evaluate, and improve standard operating procedures (SOPs), protocols, and test methods (MTHDs) as applicable.
• Ensure a compliant workspace by adhering to and enforcing GxP requirements.
• Support and/or lead out of specification (OOS) and out of trend (OOT) investigations and implement corrective actions (CAPA) as needed to prevent recurrence.
• Provide technical expertise for test methods and help troubleshoot invalid assays when needed to improve assay performance.
• Support in review testing performed by other team members
• Ensure timely escalation of all assay or equipment related challenges/issues and assist in developing countermeasures/solutions; identify potential risks in testing and escalate as needed to prevent delays.
• Track / trend key performance indicators (KPI) with the goal to maintain business continuity
• Maintain assigned items on applicable dashboards.
• Participate and/or lead Continuous Improvement (CI) and Gemba walk activities to help improve the overall operations of the testing labs.
• Maintain analytical laboratory in a state of control, compliance, and inspection readiness.
• Interface with all auditors (internal and external) to ensure positive audit outcomes and address any observations, as needed.
• Ensure and support a safe and compliant working environment per EH&S guidance.
• Expect and support Ad-hoc and cross-functional projects per business needs and provide developmental opportunities.

Education & Experience

• Bachelor's degree in a life sciences discipline required
• 1+ years of experience in a GMP regulated Biologics or Pharmaceutical environment required
• GMP experience inclusive of Compendia (USP, EP, etc.,) and FDA guidelines preferred

Knowledge, Skills, & Abilities

• Knowledge of Compendia (USP, EP, etc) and FDA guidelines through GMP experience
• Fundamental knowledge of chemistry and molecular biology
• Knowledge and understanding of 21 CFR 210/211, USP, EP and ICH guidelines
• Strong technical writing skills with experience preparing: SOPs, analytical tests reports, qualification / validation protocols and reports, method development / feasibility / verification / validation protocols and reports
• Proficient, effective, and prompt verbal and written communication skills
• Ability to understand and work with a sense of urgency and accountability
• Ability to multitask across multiple functional areas while keeping up with deadlines
• Ability to be timeline focused, proactive in taking initiative to remove roadblocks that interfere with the completion of assigned tasks and be flexible in work schedule to meet the demands of a multi-product biopharmaceutical company
• Supportive, cooperative, and reliable member of the team
• Demonstrates self-awareness, and is accepting of constructive feedback
• Consistently demonstrates excellent work ethics
• Capable of proactively evolving and growing with the company
• Strong skills in Microsoft word, Excel, PowerPoint required; Visio and Monday.com preferred.

Working Environment / Physical Environment

• This position works on-site largely during normal business hours
• Flexibility in working schedule, i.e., off-hours, overtime, second shift, and weekends based on business needs
• Occasional travel between Culver City and El Segundo offices
• GMP analytical lab environment with proper use of PPE
• Travel approximately 10%

This position is eligible for a discretionary bonus and equity award. The hourly 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.

$32.00 (entry-level qualifications) to $35.00 (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.