Director, Cell Therapy QCA

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 Director, Cell Therapy Quality Control Analytical (QCA) will direct the design, planning, implementation, budgeting, and compliant operation of all Quality Control (QC) aspects of the commercial cell therapy programs. This role is responsible for the authoring and ownership of QC sections for global regulatory applications, as well as regulatory support functions for inspections, information requests or other similar requests. The Director, Cell Therapy QCA will act as the intermediary with Manufacturing, QA and other applicable groups for the coordination of work within the QC labs to report data supporting in process, lot release, stability, characterization, in use or other testing. This position will oversee the QC analytical method lifecycle including transfers, validations, verifications, troubleshooting, and trending.

Essential Functions

• Provide ownership and oversee the authoring, and maintenance for all assigned regulatory applications including IND, BLA, and other global documents.
• Act as the Quality Control Analytical (QCA) Chemistry, Manufacturing and Controls (CMC) team representative and liaison to coordinate all In Process, Lot Release, Stability, Characterization or other testing.
• Draft, review and approve methods and documentation including product specifications; protocols, SOPs, reporting of testing, analytical method development and validation and stability studies. Design and implement strategies to transfer methods into QCA groups.
• Oversee the performance of designated staff. Responsibilities include interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems.
• Ensure QCA decisions and strategies align with Quality System, Good Manufacturing Practices (GMP) and regulatory requirements.
• Provide and monitor budgets for current and future operations including spending reports.
• Drive all inspection readiness programs and maintenance for QC cell therapy programs.
• Oversee the review of lab data, trending, and other programs to ensure appropriate, reliable, QC data.
• Lead investigations related to analytical issues and troubleshooting and provide updates to the CMC team.
• Perform all other aspects of operating a commercial program as the QC representative.
• Ad-hoc and cross-functional projects may be assigned to support business needs and provide developmental opportunities.
  
  

Education & Experience

• Bachelor’s degree in biology, chemistry or other scientific related field with 15 years of related quality experience; or
• Master’s degree in biology, chemistry or other scientific related field with 10 years of related quality experience; or
• Ph. D in biology, chemistry or other scientific related field with 8 years of related quality experience,
• 8 years at the management level with experience in cGMP lab operations within the pharmaceutical industry.
• Proven track record of successfully leading QC teams, driving quality initiatives, and managing regulatory inspections required
• Experience with a start-up pharmaceutical company preferred.
  
  

Knowledge, Skills, & Abilities

• Extensive experience drafting regulatory documents for cell therapy IND and BLAs, including method validation sections.
• In-depth knowledge in cell therapy QCA assay panel, analytical method development and validation/transfer, and statistical quality control.
• Thorough understanding of biologics manufacturing processes, including cell culture, and analytical characterization techniques.
• Ability to use sound scientific judgment in management of the facility and processes to prevent regulatory action.
• Understanding of GMPs and an ability to interpret and enforce regulatory requirements.
• Ability to work with contractors and suppliers, ensuring compliance with company standards and contractor systems.
• Demonstrated track record in managing a staff and establishing a clear, strategic direction.
• Ability to develop a high-morale organization with leaders, teams, and groups, and appropriately staff the QC department to meet business needs.
• Ability to analyze and interpret complex, scientific documents, including problem solving.
• Ability to multi-task and prioritize with excellent project management skills.
• Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects simultaneously.
• Excellent communication skills, with the ability to effectively interact with cross-functional teams, senior management, and external entities.
  
  

Working Environment / Physical Environment

• This position works on-site in El Segundo, CA
• Performs work in the lab or office as needed to oversee cell therapy quality control programs
  
  

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.

$185,000 (entry-level qualifications) to $220,000 (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.