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Senior Associate, Quality Control Analytical

Company

ImmunityBio

Address ,
Employment type FULL_TIME
Salary
Expires 2023-10-11
Posted at 9 months ago
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?
  • Work with a collaborative team with the ability to work across different areas at the company.
  • Opportunity to join an early-stage public biopharmaceutical company with a headquarters in Southern California.
  • Ability to join a growing company with development opportunities.
  • 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.
Position Summary
The Senior Associate in the Quality Control department is responsible for ensuring the timely execution of Quality Control Analytical assays in support of product release across all of Immunity Bio’s oncology product platforms. This position requires expertise with cell culture and cell based assays. The position requires experience with the performance as well as the qualification/validation of GMP quality control assays.
This role will interact cross-functionally with members of the Manufacturing, Quality Assurance, Analytical Development, and Process Sciences teams. The successful candidate is a proficient communicator (written and verbal), can multitask across multiple functional areas, is timeline focused, is proactive in taking initiative to remove roadblocks that interfere with the completion of assigned tasks and has flexibility in their work schedule in order to meet the demands of a multi-product clinical phase biopharmaceutical company.
Essential Functions
Ensuring prompt scheduling, processing and testing of all activities assigned in support of in-process and release testing to support all ImmunityBio products. Specific duties include:
  • Support and/or lead out of specification and out of trend investigations and implement corrective actions as needed to prevent reoccurrence.
  • Ensure timely escalation of all assay related challenges/issues and assist in developing countermeasures to improve performance.
  • Partner with colleagues in various departments (e.g., AD/PD, Facilities, Engineering, QA and Regulatory) to ensure achievement of company goals.
  • Ensure and support a safe working environment for work areas.
  • Perform cell culture to support cell based assays
  • Ensuring the integrity of all data generated.
  • Support instrument installation and operational qualification activities (IOQ).
  • 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. Interface with all auditors (internal and external) to ensure positive audit outcomes.
  • Competent in handling and maintaining mammalian cell culture in a BSL2 Laboratory is required.
  • May conduct other Quality Control related duties as assigned.
  • Participate in method qualification, validation and transfer activities.
  • Lead the testing of assigned lot release and stability samples to meet expected turnaround time requirements.
  • Track / trend key performance indicators and identify adverse events in testing and escalate as needed to prevent reoccurrence.
  • Support the Continued Process Verification (CPV) program for fusion drug product
  • Provide technical expertise for test methods and help troubleshoot invalid assays when needed to improve assay performance.
  • Ensure a compliant work space by adhering to and enforcing GxP requirements.
  • Approve testing performed by other team members to ensure timely release of test data.
Education & Experience
  • Bachelor’s degree in a life sciences discipline with 2-5 years of experience in a GMP regulated Biologics or Pharmaceutical environment.
  • Experience with the technical transfer and qualification/validation of analytical assays.
  • Strong knowledge of Cell based assays Including Flow cytometry, plate based and PCR –based assays.
Knowledge, Skills, & Abilities
  • Excellent skill in Microsoft word, Excel and data analysis using FlowJo and Statistical programs (Prism and JMP).
  • Strong technical writing skills with experience preparing: SOPs, analytical tests reports, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.
  • A demonstrated knowledge and understanding of 21 CFR 210/211, USP, EP and ICH guidelines.
  • Fundamental knowledge of cell and molecular biology and immunology
  • Strong problem-solving skills with demonstrated attention to detail.
Working Environment / Physical Environment
  • Travel approximately 10%
  • Exposure to onsite in-lab environment
  • Flexibility in working schedule, i.e., off-hours, second shift, and weekends.
  • Ability to work full time on-site
  • All hires are based upon completion and passage of a background check.
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.
$34.00 (entry-level qualifications) to $39.00 (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.