Senior, IT GXP Systems Specialist

Company Overview
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
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 IT GxP Systems Specialist position will manage day-to-day system administration, user support and implementation of GxP computerized systems for laboratories, manufacturing and other regulatory operations.  In close partnership with R&D, Quality Control, Engineering and Manufacturing functional leads, the position will provide technical leadership for new system deployments, upgrades, and maintenance of GxP systems including networked and non-networked stand-alone equipment at multiple ImmunityBio sites.

Essential Functions

• Responsible for implementing and maintaining software supporting GxP laboratory equipment.
• Responsible for daily GxP system operations, maintenance, and support.
• Create and maintain system documentation, specifications, IT administrative and security SOPs and execute test scripts related to GxP systems to support Computer System Validation Systems Validation (CSV).
• Follow IT and Quality processes to maintain systems in a validated state and ensure GxP systems are in compliance with 21 CFR part 11.
• Manage incident tickets, perform troubleshooting and periodic assessments of systems.
• Evaluate and assign appropriate data security, user roles and privileges for data integrity.
• Coordinate with system vendors and business partners in various functions to schedule upgrades, maintenance, and support activities.
• Flexibility to provide 24 x 7 IT support for operations.
• Create and maintain service catalog related to IT GxP operations.
• Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs.

Education & Experience

• Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related field with 4+ years of hands-on Systems Administration experience supporting end-users, servers, applications, storage, and networking in a pharmaceutical or related industry is required; OR
• High School Diploma or equivalent with 8+ years of hands-on Systems Administration experience supporting end-users, servers, applications, storage, and networking in a pharmaceutical or related industry is required.
• 1+ years of providing IT support in a GxP environment is preferred.

Knowledge, Skills, & Abilities

• Strong understanding of Windows operating systems, networking protocols (TCP/IP, DNS, DHCP), VLANs, wireless access points, IP addresses, group policies, and user/group management security.
• Working knowledge of FDA cGMP and cGLP regulations including 21 CFR Part 11.
• Strong experience in customer service, incident management, and problem management.
• Strong technical, analytical, and business acumen with excellent attention to detail.
• Strong interpersonal and communication skills
• Strong troubleshooting and problem-solving skills, with the ability to learn and adapt to new technologies and processes quickly.
• Ability to manage multiple projects simultaneously while performing day-to-day activities.
• Ability to present technical information to management, employees, and other departments.
• Excellent interpersonal, written and verbal communication skills.
• Excellent ability to write, review, edit, and approve technical documentation.
• Ability to pivot and work well in complex, fast-paced environments.
• Strong leadership and influence skills with demonstrated business partnering approach.
• Proactive and self-motivated team player with exceptional organization, follow-through, time management, and communication skills.
• Proven ability to work collaboratively in a matrix organization.

Working Environment / Physical Environment

• This position will be onsite.
• Regular work schedule is Monday – Friday, within standard business hours.  Flexibility is available with manager approval.
• Participate in On-Call rotation for after-hours support and may work outside of established shift hours upon short notice to address any emergencies
• Exposure to onsite in-lab environment
• Must be able to don and wear Personal Protective Equipment (PPE) as required
• 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 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.

$54.52 (entry-level qualifications) to $60.57 (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 uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.

Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.

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.