IB Temporary - 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 IB Temporary - Associate in the Quality Control department is responsible for ensuring the timely execution of Quality Control Analytical assays in support of product release across all of Immunity Bio’s oncology and vaccine product platforms. This position requires expertise with molecular biology and/or chemistry assays utilizing cell culture, ELISA, HPLC, icIEF and CE-SDS techniques.   The position requires experience with analytical development as well as qualification/validation of GMP quality control assays.

This role will interact cross-functionally with members of the Manufacturing, Quality Assurance, Analytical Development, and Process Sciences teams. 

Essential Functions

• Ensure and support a safe working environment for work areas.
• Lead the testing of assigned lot release and stability samples to meet expected turnaround time requirements. 
• Participate in method qualification, validation and transfer activities.
• Support instrument installation and operational qualification activities (IOQ).
• Ensure a compliant work space by adhering to and enforcing GxP requirements.
• Support and/or lead out of specification and out of trend investigations and implement corrective actions as needed to prevent reoccurrence. 
• Approve testing performed by other team members to ensure timely release of test data.
• Ensuring the integrity of all data generated.
• Provide technical expertise for test methods and help troubleshoot invalid assays when needed to improve assay performance.
• Ensure timely escalation of all assay related challenges/issues and assist in developing countermeasures to improve performance. 
• Track / trend key performance indicators and identify adverse events in testing and escalate as needed to prevent reoccurrence. 
• Participate and/or lead continuous improvement 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.
• Partner with colleagues in various departments (e.g., AD/PD, Facilities, Engineering, QA and Regulatory) to ensure achievement of company goals. 
• May conduct other Quality Control related duties as assigned.

Education & Experience

• Bachelor’s degree in a life sciences discipline with 3+ years of relevant experience required.
• Strong knowledge of analytical molecular biology assays preferred.
• Experience with the technical transfer and qualification/validation of analytical assays preferred.

Knowledge, Skills, & Abilities

• Fundamental knowledge of cell and molecular biology, immunology, and virology.
• 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

• Flexibility in working schedule, i.e., occasional off-hours, second shift, and weekends.
• Exposure to onsite in-lab environment.
• Regular work schedule is Monday – Friday, within standard business hours.  Flexibility is available with manager approval.
• Will require occasional weekend and holiday work to meet business needs.
• 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.

$32.40 (entry-level qualifications) to $36.00 (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.