Specialist, Quality Control Analytical

Company: ImmunityBio
Location: San Diego
Posted on: November 18, 2023

Job Description:

ImmunityBio, Inc. is a late-stage immunotherapy company developing 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." 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 Specialist, Quality Control Analytical will provide testing support for the Recombinant fusion protein program through lot release assays such as Cell-Based Potency assays. The position will also take on a lead role for one function of the lab, providing expertise and understanding of the process when needed. The role will undertake complex laboratory and documentation tasks, including the creation of in-depth reports and execution of highly involved testing protocols. Additionally, the position will support sample preparation teams, complete investigations, and operations such as cell culture, sample thawing and preparation, lab equipment preventive maintenance, buffer preparation, supply inventory management, and general support tasks in order to allow the lab to continuously operate. Essential Functions

• Leads Potency function of the lab, providing expertise as needed
• Competent in handling and maintaining mammalian cell culture in a BSL2 Laboratory is required.
• Provides testing support through In Process, Lot Release and Stability testing, method transfers, and suitability for use testing
• Supporting of the Continued Process Verification (CPV) program for the trending of direct fusion drug products.
• Create and maintain metrics for assay performance and lab operations
• Completes investigations and other associated analytical documentation and trending
• Creates in-depth reports and highly involved testing protocols
• Performs Cell Culture, Lab Maintenance, and Lab Support Functions including completing maintenance records and cell culture reports and deliverables
• Critical reagent qualification
• Provides Quality Systems and Documentation Support and completes Change Requests, SOP and Test Method updates, and associated documents
• Track / trend key performance indicators and identify adverse events in testing and escalate as needed to prevent reoccurrence
• Participate and/or lead continuous improvement activities to help improve the overall operations of the testing labs
• Maintain analytical laboratory in a state of control, compliance, and inspection readiness
• Supports sample preparation teams
• Partner with colleagues in various departments (e.g., AD/PD, Facilities, Engineering, QA and Regulatory) to ensure achievement of company goals
• May conduct other Quality Control related duties as assigned Education & Experience
  • Bachelor's degree in Cell Biology or Immunology or related discipline in Biology preferred with 4+ years of experience in Biotechnology industry
  • Or Master's degree with 2+ years of industry experience
  • Experience working with mammalian cells preferred Knowledge, Skills, & Abilities
    • Excellent interpersonal, communication, organizational, and problem-solving skills
    • Working knowledge of QC testing requirements, methodology, and equipment such as Cell Culture, Cell Counters, Plate Readers, and Flow Cytometry
    • Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics
    • Flexibility and the ability to thrive in an efficient, highly interactive, goal-oriented team environment.
    • Knowledge of MS Word and Excel Working Environment / Physical Environment
      • Ability to work full time on-site The 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. $38.00 (entry-level qualifications) to $48.00 (highly experienced) 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 15 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and and 1 Cultural Day* We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. 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 15 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 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.

Keywords: ImmunityBio, San Diego , Specialist, Quality Control Analytical, Other , San Diego, California