Specialist, Manufacturing GMP Investigations

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 Specialist, Manufacturing GMP Investigations is responsible for writing and owning quality records for GMP Manufacturing Operation activities in support of the release of product. This position provides a unique opportunity to make an immediate impact and lay the foundation for processes and procedures in a fast-paced dynamic environment.

Essential Functions

• Support clinical product final disposition by leading investigations for significant deviations, change controls and corrective/preventative actions and manage closure within the established timelines to meet patient supply.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to cell therapy, as well as technical understanding/problem solving capability.
• Responsible for organizing data and preparing appropriate documentation, including presentation materials, for assigned projects.
• Perform document change control activities. Write, edit, and review of controlled documents to ensure documents comply with applicable regulatory requirements.
• Participate in regular site and Quality/Manufacturing meetings.
• Participate in audits and regulatory inspections as assigned.
• Other duties as assigned.

Education & Experience

• Bachelor's degree in biological science, chemistry, or related scientific field.
• 2+ years of experience in the pharmaceutical/biopharmaceutical industry.
• Working knowledge of biologics cGMP manufacturing ideally including recombinant protein and cell therapy cGMP manufacturing.

Knowledge, Skills, & Abilities

• 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.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities.
• Exceptional organization and time-management skills, ability to deliver under deadlines.

Working Environment / Physical Environment

• This position works on-site, primarily in an office environment.
• Local travel between facilities in El Segundo and Culver City may be required.

• Occasionally this position may need to work in a lab environment and requires the ability to wear the appropriate PPE in specified GMP areas.

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.

$38.00 (entry-level qualifications) to $47.00 (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.

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.