ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company's immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory." The U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio's resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guerin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease, and has set a user fee goal date (PDUFA date) of April 23, 2024.

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 an early-stage public biopharmaceutical company with a headquarters in Southern California.

* Work with a collaborative team with the ability to work across different areas at the company.

* Ability to join a growing company with development opportunities.

Position Summary

The Quality Control Senior Associate will support the facility environmental and utility monitoring (EM) programs in support of sterile product manufacturing, to include sampling, testing, and data management of the collected samples, training personnel on aseptic technique and aseptic gowning, complete investigations, and support lab operations such as equipment preventive maintenance, supply inventory management, and general support tasks in order to allow the lab to continuously operate. The position will also provide leadership and guidance to junior analysts, support method/SOP revisions, study protocols, method transfers, and qualifications. The incumbent may also support lab assays for lot release and stability testing, participate in sample preparation and aliquoting, media lot release testing.

Essential Functions

• Organize daily workload schedule and relevant resource requirements.
• Participate in authoring complex, explicit documentation for manufacturing operations.
• Environmental and Critical Systems monitoring, testing, review, reporting, and trending. Reviewing of data, trending, and applicable investigations.
• Support all compliance aspect related to microbiological and analytical testing and will support investigations and root cause analysis.
• Play a critical role in working collaboratively with manufacturing technicians and associates in support of EM.
• Routine and validation sample testing under GMP or non-GMP modes, laboratory maintenance, and assist in method or equipment qualification/validations.
• Responsible for laboratory maintenance to include cleaning and sanitization of laboratory equipment, laboratory restocking of supplies and inventory.
• Coordinate and generate Risk Assessments.
• Assist with the drafting of controlled documents including Protocols, Reports, SOPs, Test Methods, Specifications and Work Instructions, data entry and reporting
• Perform other duties as assigned.

Education & Experience

• Bachelor's degree in a life sciences discipline with 2-4 years of experience in a GMP regulated Biologics or Pharmaceutical environment.
• Experience in cGMP aseptic processing facility is a plus

Knowledge, Skills, & Abilities

• Knowledge of regulatory expectations for QC Microbiology department
• Knowledge of environmental and critical utilities monitoring, personnel monitoring, aseptic processing, and microbiological testing assays.
• Fundamental knowledge of microbiology (knowledge of cell and molecular biology, immunology, and virology is a plus).
• Strong technical writing skills with experience preparing: SOPs, analytical tests reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.
• Strong problem-solving skills with demonstrated attention to detail.
• Good understanding and demonstration of aseptic techniques.
• Proficient in Microsoft Word, Project, and Excel
• Ability to perform troubleshooting and develop solutions to problems of moderate scope in complexity.
• 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.
• Well-developed written and oral communication skills; motivated to work in a team environment.
• 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.
• Ability to multi-task and retain flexibility in a dynamic environment.
• Consistently deliver on commitments

Working Environment / Physical Environment

• This role will work onsite in El Segundo, CA
• Flexibility in working schedule, i.e., off-hours, second shift, weekends and holidays to meet business needs
• Ability to gown into cleanroom for extended period of time
• Exposure to onsite in-lab environment
• Travel approximately 10%

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

$34.00 (entry-level qualifications) to $39.00 (highly experienced) hourly

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.