Senior Scientist, 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 Scientist, Quality Control Analytical provides analytical testing leadership for various programs such as fusion proteins, cell therapies and cancer vaccines. The analytical testing will include but is not limited to the wet chemistry, chromatography (HPLC, Capillary Electrophoresis), spectroscopy (UV-Vis), and ELISA. The position will also take on a lead role for providing testing support through In Process testing, and suitability for use testing, method development, optimizations, transfer, qualification work and investigational studies. The Senior Scientist will undertake complex troubleshooting and investigations.

Essential Functions

• Develop strategies, and support the introduction, validation and on-going technical agenda for pipeline and commercial analytical chemistry methods and technology. Including:
  • The polishing of analytical methods to implement GMP-friendly structure into the method.
  • Drafting and reviewing of protocols, reports, and methods to support the method validation lifecycle.
  • Complex troubleshooting of methods
  • Development of new assays to support raw material, in process, drug substance, or drug product release and stability testing.
• As required, provide training or mentorship to other QC or cross functional team members.
• Act as Subject Matter Expert (SME) for analytical chemistry within QC. This may include the identification, purification and separation of the components in an unknown mixture.
• Complete structural analytical characterization (via experimental analysis or review of outsource reports) on various drug products, including product related impurities.
• In the event of non-conformance to acceptable quality and/or safety standards (including invalid assays), lead analytical investigations, using Root Cause Analysis techniques where appropriate. Work with the QC team to improve the state of validation and drive analytical variability reduction.
• Draft and edit documents, Standard Operating Procedures (SOPs) and test plans as needed.
• Lead continuous improvement activities to help improve the overall operations of the testing labs.
• Track / trend key performance indicators and identify adverse events in testing and escalate as needed to prevent reoccurrence.
• Partner with colleagues in various departments (e.g., AD/PD, Facilities, Engineering, QA and Regulatory) to ensure achievement of company goals.
• Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Education & Experience

• Master's degree in Analytical Science (chemistry, biochemistry, or other scientific related field) with at least 7 years of experience in the biotechnology industry required; or
• Ph.D. in Analytical Science (chemistry, biochemistry, or other scientific related field) with at least 3 years of experience in the biotechnology industry required.
• Extensive experience with assay development, qualification, validation, and transfer activities.
• Experience working in cGMP laboratory required
• Hands-on experience with HPLC and ELISA required
• Hands-on experience with biological assays (e.g. cell cultures) preferred

Knowledge, Skills, & Abilities

• Working knowledge of QC testing requirements, methodology, and general equipment such as pH meter and analytical balance
• Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics
• With safety as the priority excellent laboratory techniques
• Proficiency in the use of multiple HPLC instrument platforms (e.g. Thermo, Agilent, etc.)
• Strong technical problem-solving ability both independently and as part of a team.
• Motivated to work independently to produce high quality work in an efficient manner.
• Strong computer skills, including Microsoft Office
• High attention to detail in all aspects of the work
• 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.
• Ability to use sound scientific judgment in management of the facility and processes to prevent regulatory action.
• Deep understanding of GMPs, SOPs, and pharmaceutical regulations, and an ability to interpret and enforce regulatory requirements.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to analyze and interpret complex, scientific documents, including problem solving.

Working Environment / Physical Environment

• This position works on site in Dunkirk, NY
• Flexibility in working schedule, i.e., off-hours
• Performs work in the lab as needed to supervisor staff and oversee quality control programs.
• Performs work in the lab to execute experiments.

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.

$125,000 (entry-level qualifications) to $137,500 (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.