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 Bioanalytical Data Specialist will be responsible for managing data generated in the Process Development and the bioanalytical testing laboratory.

The position will contribute to process improvements within the department and consolidation of the bioanalytical data for the exploratory studies.

Essential Functions

• Create and review study-specific forms using protocol-specific information.
• Generate and organize study data using software like Excel and / or JMP for data trending. Work closely with lab scientists to perform data trending in real time.
• Generate bioanalytical data templates with desired calculations using Excel and / or JMP software
• Manage data template and update accordingly, lead the data management program by training the lab scientist(s) on the best way for data recording.
• Manage clinical data management for exploratory studies in a compliant manner ensuring complete record of all the data related activities including data migration, transfer, calculation, conversion, data template revision etc.
• Work with senior management and make recommendations when applicable to produce finalized bioanalytical data files following the data transfer agreement (DTA) requirements effectively incorporated into finalized deliverables in a timely manner.
• Manage and serve as subject matter expert for the database for the study-specific bioanalytical team, including the compilation of edit checks.
• Generate status reports and requested metrics, which may include query information or data trends for study-specific team meetings.
• Partner with sample management team for efficient sample information transfer using automated methods.
• Perform data review and query generation / closure.
• Train internal colleagues in bioanalytical data management in either informal or formal settings as needed.
• Performs other duties and projects as assigned.

Education & Experience

• Bachelor's degree in a science-related field.
• 2 years of bioanalytical data management experience.
• Knowledge of bioanalytical testing, GXP / GDP, and regulatory requirements / guidelines.
• Experience with demonstrated capabilities in building and maintaining bioanalytical databases.

Knowledge, Skills, & Abilities

• Good organizational and time-management Skills
• Detail-oriented and good interpersonal skills
• Demonstrated statistical analysis skills using JMP software with ability to clearly present findings visually.
• Proficient in Microsoft Office, JMP software and database management
• Knowledge of test protocols and test development inclusive of technical report writing and / or documentation

Working Environment / Physical Environment

This position works onsite in a lab environment.

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.

$68,000 (entry-level qualifications) to $78,000 (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.

Last updated : 2024-06-17