Scientist I, Analytical Development - Process Sciences

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 Scientist I, Analytical Development - Process Sciences will provide analytical support across ImmunityBio’s biologics platforms to advance our pipeline. The role is responsible for analytical testing, method development, and method qualification/validation in support of process development activities.  The role will also assist in data review, technical writing, and training of junior team members. Alongside Process Sciences and Analytical Development (AD), the role supports AD management and Regulatory Affairs with regulatory filings and will require cross-functional interactions with Manufacturing, Quality Assurance, Quality Control, and Process/Product Development teams.

Essential Functions

• Perform analytical testing, product characterization, and method development for various biologics products, especially proteins.
• Support internal and external method transfers, method qualification, and method validation
• Author and review data, analytical methods, SOPs, protocols, and reports.
• Support Process Development to characterize process improvements and develop new products.
• Oversee the training and development of junior associates/specialists as the team grows.
• Maintain, calibrate, and operate analytical equipment and instruments.

• Interface with other departments (e.g., QC, Manufacturing, Engineering, QA and Regulatory) to ensure achievement of ImmunityBio’s goals.

• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor’s degree in a scientific discipline with 8+ years of relevant experience in a GMP or GLP regulated Biologics or biopharmaceutical environment required; or
• Master’s degree in scientific discipline with 6+ years of relevant experience in a GMP or GLP regulated Biologics or biopharmaceutical environment required; or
• PhD in scientific discipline with relevant industry or post-doctoral academic experience required.
• Hands-on experience with high-performance liquid chromatography (HPLC) or capillary electrophoresis (CE-SDS, ic-IEF) required.
• Hands-on experience with osmolality, pH, conductivity, UV-Vis, Karl-Fischer, and other analytical techniques preferred.
• Experience with protein characterization and analytical method development strongly preferred
• Experience with method qualification, method validation, or method transfer a preferred.

Knowledge, Skills, & Abilities

• Working knowledge of cGMP, and ability to adhere to pharmaceutical regulations (21 CFR 210/211, USP, EP and ICH guidelines)
• Ability to collaborate with contract testing laboratories, consultants, ensuring compliance with company procedures
• Knowledge of formulation development, statistical analysis, mass spectrometry, and biophysics
• Knowledge of analytical chemistry and chromatography, cell and molecular biology, immunology, and/or virology
• Adept at instrumentation trouble shooting
• Strong verbal and written communication skills, with technical writing experience preparing SOPs, analytical test reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA regulatory filings.
• Problem solving skills with attention to detail
• Strong time management skills
• Highly motivated and able to excel in a fast-moving environment
• Team player who is capable of identifying creative solutions and has a genuine interest in establishing/expanding analytical workflows and capabilities

Working Environment / Physical Environment

• This position works on site, in Louisville, CO as noted in the offer letter.
• Regular work schedule is Monday – Friday, within standard business hours.  Flexibility is available with manager approval.
• Working environment is within a GMP BSL-2 laboratory with equipment sufficient to complete the tasks described above.
• Travel up to 10%.
• Occasionally: transporting small equipment, frequent bending, sitting, squatting and lifting up to 40 lbs.

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.

$107,500 (entry-level qualifications) to $118,000 (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 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.