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 Senior Specialist, GxP Training will serve as Subject Matter Expert (SME) for the electronic Learning Management System (LMS), providing guidance to internal stakeholders and facilitating training as needed. The role will process training requests, create and update electronic training plans, and curricula, and contribute to the development of training strategies, processes, and procedures that ensure alignment with internal policies, procedures, and regulatory requirements. The Senior Specialist also supports the design, implementation, and ongoing administration of eLearning authoring to enhance content delivery.

Essential Functions

• Partner with senior leadership to foster a learning culture and implement advanced technical training strategies and solutions.
• Lead and deploy technical training initiatives that align with business goals, regulatory compliance, and organizational productivity.
• Collaborate with trainers and subject matter experts to design, develop, and maintain training content using sound instructional design methodologies.
• Create interactive e-learning experiences and high-impact course content to enhance engagement and retention.
• Process training requests, and create and update electronic training plans, and curricula
• Generate and report training data to internal and external stakeholders, to assist in executing periodic training reviews, and identifying training needs.
• Support audit readiness by retrieving and submitting documentation and data promptly for internal and external audits and inspections upon request.
• Develop supporting media and materials, including audio, video, simulations, and gamified learning tools.
• Research, evaluate, and recommend adult learning methods and emerging technologies for integration into training programs.
• Assist in the development and implementation of performance metrics to evaluate technical training effectiveness.
• Perform additional related duties as assigned to support training operations and strategic initiatives.

Education & Experience

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline required.
• 7+ years of experience in a GMP-regulated Biologics or Pharmaceutical environment required.
• Experience and familiarity with global quality standards, Quality Management System regulations, and cGMP requirements related to documentation, and training required.
• Proficiency in GMP Quality Systems such as EtQ Reliance, Trackwise, ComplianceWire, LIMS, and Veeva Vault preferred.
• Hands-on experience with eLearning authoring tools; proficiency in Articulate Storyline 360 strongly preferred.
• Experience in Project Management is preferred.

Knowledge, Skills, & Abilities

• Excellent communication skills with the ability to collaborate across multiple teams and projects.
• Able to prepare written communications with clarity and accuracy.
• Ability to work collaboratively with others from any functional area or background, to influence thinking, and gain acceptance.
• Strong authorship and ability to communicate effectively across the entire ImmunityBio organization on matters related to documentation and knowledge management systems. Able to prepare written communications with clarity and accuracy.
• Must be able to work independently with the ability to complete routine tasks with little or no supervision.
• Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills with a strong sense of personal accountability for work tasks.
• Able to respond to challenges and additional projects in an understanding, positive, and objective manner; adaptable to dynamic conditions, work practices, and project timelines.
• Able to exercise judgment within defined practices and policies in selecting methods and techniques for obtaining solutions and/or taking appropriate actions
• Desired proficient in E-Learning software (Storyline, Captivate)
• Must be proficient in Microsoft Office (Excel, Word, Access, Power Point, Visio) and Adobe Professional software.
• Experience with Microsoft Project is preferred.

Working Environment / Physical Environment

• This position works on site with exposure to lab environments.
• Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Lift and carry materials weighing up to 20 pounds.

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.
$99,000 (entry-level qualifications) to $110,000 (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

• Partner with senior leadership to foster a learning culture and implement advanced technical training strategies and solutions.
• Lead and deploy technical training initiatives that align with business goals, regulatory compliance, and organizational productivity.
• Collaborate with trainers and subject matter experts to design, develop, and maintain training content using sound instructional design methodologies.
• Create interactive e-learning experiences and high-impact course content to enhance engagement and retention.
• Process training requests, and create and update electronic training plans, and curricula
• Generate and report training data to internal and external stakeholders, to assist in executing periodic training reviews, and identifying training needs.
• Support audit readiness by retrieving and submitting documentation and data promptly for internal and external audits and inspections upon request.
• Develop supporting media and materials, including audio, video, simulations, and gamified learning tools.
• Research, evaluate, and recommend adult learning methods and emerging technologies for integration into training programs.
• Assist in the development and implementation of performance metrics to evaluate technical training effectiveness.
• Perform additional related duties as assigned to support training operations and strategic initiatives