Senior Manager, Quality Control Analytical

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 Manager, Quality Control Analytical will be assigned responsibilities for the management of laboratory testing activities for various programs (fusion proteins, cell therapies and cancer vaccines), routine preventive maintenance, and completing lab administrative duties. The position will be responsible for providing testing support through In Process testing, suitability for use testing, method development, optimizations, transfer, qualification and investigational studies. The analytical testing includes wet chemistry, chromatography (HPLC, Capillary Electrophoresis), spectroscopy (UV-Vis), and ELISA, but not limited to. The position will be required to oversee and coordinate method troubleshooting and investigations. Creating protocols and reports will also be required, using knowledge of GMP/cGMP practices to incorporate the appropriate regulatory requirements into the methods and procedures.

The position provides onsite oversight of a wide variety of complex tasks that support the establishment, transfer of the methods into the other QCA lab, and perform various investigational testings.

Essential Functions

• Oversight and scheduling of analytical testing for In Process testing, suitability for use testing, method development, qualification, optimizations, transfer and investigational studies.
• Oversight of the QC Analytical lab staff, including hiring, training functions, 1:1 meetings, and career development for QCA staff.
• Interface as QCA member to interact with other departments to coordinate activities.
• Review of assay protocols and reports in line with commercial GMP standards.
• Backup analyst for completing assays.
• Participate and coordinate method development, optimization, transfer, and qualification work (protocol drafting, data collection, and report writing). 
• SOP and Test Method drafting and revisions.
• Ensure quality control staff, equipment, and procedures are compliant to regulatory guidelines and data integrity principles are adhered to.
• Performs other projects and duties as assigned.

Education & Experience

• Bachelor’s degree in Cell Biology or Immunology or related discipline with 8+ years’ of relevant experience in the biotechnology industry with emphasis in analytical development or quality control testing required; OR
• Master’s degree in Biology or related discipline with 6+ years of relevant experience in the biotechnology industry with emphasis in analytical development or quality control testing required
• Experience with QC testing requirements, methodology and equipment such as HPLC and Plate Readers required
• Experience leading a team in a GMP environment strongly preferred
• Demonstrated self and team adaptability under changing circumstances to deliver results

Knowledge, Skills, & Abilities

• Demonstrated understanding of QC testing requirements, methodology and equipment such as HPLC and Plate Readers.
• Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics
• Knowledge of MS Word, PowerPoint, and Excel
• Ability to work independently and within cross-functional teams to deliver on project timelines and department goals.

Working Environment / Physical Environment

• This position works on-site in Dunkirk, NY
• This position works in a lab environment
• Flexibility in working schedule, i.e., off-hours
• Must be able to gown and gain entry to labs
• 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 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.

$145,000 (entry-level qualifications) to $159,500 (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 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.