Scientist I, Process Sciences - Analytical Development

Location: Louisville, CO

Time Type: Full time

Job Description

Company Overview
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease.

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, Process Sciences - Analytical Development will work alongside Process Sciences and Analytical Development (AD) team members to contribute to our efforts to develop and implement methods across ImmunityBio’s platforms, and the advancement of our pipeline by collaborating with internal and external partners. The role is responsible for method development and ensuring timely execution of samples in support of process development activities.   The Scientist I, Process Sciences - Analytical Development will assist in data review, method qualification and/or validation, and training of junior team members..   The role will support AD management and Regulatory Affairs personnel with all regulatory filings and will require  cross-functional interaction with members of the Manufacturing, Quality Assurance, Quality Control, and Process/Product Development teams.

Essential Functions

• Perform method development, optimization, and troubleshooting of analytical methods, for various product platforms with minimum supervision.
• Ensure the integrity of all data generated.
• Perform a variety of techniques to assess product quality and characterize products, including HPLC assays, UV-Vis and analytical chemistry techniques.
• Support efforts for method troubleshooting, remediation, change, and optimization efforts in conjunction with Quality Control and Analytical Development.
• Author and review analytical methods, SOPs, protocols, and reports.
• Support the Process Development teams to characterize process improvements and develop new products.
• Support internal and/or external transfers of analytical methods.
• Oversee the training and development of junior Analytical Development associates/specialists.
• Maintain, calibrate and operate analytical equipment and instruments.
• Provide technical expertise to troubleshoot assays. Ensure timely escalation of all assay related issues.
• 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 regulated Biologics or Pharmaceutical environment required; or
• Master’s degree in scientific discipline with 6+ years of relevant experience in a GMP regulated Biologics or Pharmaceutical environment required.
• Experience in method development, method validation, and method transfer is required.
• Fundamental knowledge of analytical chemistry and chromatography is required.
• Fundamental knowledge of cell and molecular biology, immunology, and/or virology a plus.

Knowledge, Skills, & Abilities

• Ability  to successfully interface with multidisciplinary teams
• Excellent verbal and written skills to communicate cross functionally
• Highly motivated, detail oriented and able to excel in a fast-moving environment.
• Expert knowledge and experience with other pharmaceutical test methods to include HPLC analysis, osmolality, pH, conductivity, UV-Vis, and Karl-Fischer
• Knowledge of quality control analytical method development, method validation and method transfer
• Problem solving skills with attention to detail
• Knowledge and understanding of cGMP, 21 CFR 210/211, USP, EP and ICH guidelines
• In-depth knowledge of GMPs and pharmaceutical regulations
• Ability to collaborate with contract testing laboratories, consultants, ensuring compliance with company procedures
• Ability to multi-task and prioritize
• Adept at instrumentation trouble shooting
• Strong statistical analysis skills
• Strong technical writing skills with experience preparing: SOPs, analytical test reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.

Working Environment / Physical Environment

• This position works on site, in Louisville, CO.
• 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.

$104,000 (entry-level qualifications) to $114,400 (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 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.