Director, Commercial QCA

2 weeks ago

Culver City, United States ImmunityBio, Inc. Full time

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-Gurin (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 Director, N-803 Commercial QCA is responsible for the design, planning, implementation, and operation control of quality control programs to ensure product reliability, quality, efficacy, and compliance to applicable state, federal, and country-specific regulations including cGMPs and internal standards for manufacturing, materials and finished products related to the commercial N-803 program.

Essential Functions

  • Ensure the compliant (in line with all relevant guidance), efficient operations of Quality Control Analytical by overseeing all laboratory testing (in house and outsourced In Process, Lot Release, and Stability).
  • Transfer, 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 methods to increase efficiencies and productivity, and to improve knowledge of product safety, purity, efficacy, potency, and stability. Design and implement strategies to transfer methods into QCA groups.
  • Ensure QCA decisions align with Quality System, GMP and regulatory requirements.
  • Provide budgets for current and future operations including strategy and plans for laboratory relocations and new laboratory implementation.
  • Develop and mentor the Analytical Quality Control staff to perform at a commercial level of compliance.
  • 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.
  • Performs other special projects and duties as requested.
Education & Experience
  • Bachelor's degree in biology, chemistry, or other scientific related field with 15 years of related quality experience with 8+ years at the management level; or
  • Master's degree in biology, chemistry, or other scientific related field with 10 years of related quality experience with 8+ years at the management level; or
  • Ph.D. in biology, chemistry, or other scientific related field with 8+ years of related quality experience with 8+ years at the management level
  • Extensive experience with assay qualification, validation, and transfer activities.
  • Experience for a FDA PLI, Surveillance, or other inspection, with an acceptable outcome.
  • Experience with a start-up pharmaceutical company preferred
Knowledge, Skills, & Abilities
  • Thorough understanding of biologics manufacturing processes, including cell culture, purification, and analytical characterization techniques
  • Proven track record of successfully leading QC teams, driving quality initiatives, and managing regulatory inspections
  • 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
  • In-depth knowledge in analytical method development and validation, and statistical quality control.
  • In-depth knowledge of GMPs, SOPs and pharmaceutical regulations.
  • 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 communicate professionally, knowledgeably, and efficiently with a wide range of employees and with all internal and external customers, both in writing and verbally.
  • Ability to work with contractors and suppliers, ensuring compliance with company standards and contractor systems.
  • Ability to define problems, collect data, establish facts and draw valid conclusions.
  • 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.
Working Environment / Physical Environment
  • Performs work in the lab as needed to supervisor staff and oversee quality control programs
  • This role will work on site
  • Flexibility in working schedule, i.e., off-hours, second shift and weekends as needed


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.

$178,000 (entry-level qualifications) to $215,000 (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.

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