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 Principal Scientist, Analytical Development - Process Sciences will collaborate with internal and external partners to develop, qualify and implement methods across ImmunityBio's platforms and advance our pipeline. This role will serve as a key technical leader and mentor within the Process Sciences department, driving innovation in method development and characterization from early-stage development through late-stage commercialization. The Principal Scientist will support TechOps management and Regulatory Affairs personnel with regulatory filings and provide guidance and consultation to members of the Manufacturing, Quality Assurance, Quality Control, and Process/Product Development teams while overseeing timely execution of samples in support of process development activities.
Essential Functions
Lead the design, development and qualification of robust analytical methods for therapeutic proteins, viral vectors and whole cell products. This includes chromatography, electrophoresis, and cell-based or binding bioassays
Lead method transfer activities ensuring seamless transfer of assays to and from Quality Control or external Contract Development and Manufacturing Organizations
Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance
Serve as principal technical subject matter expert (SME). Provide mentorship, training and strategic guidance to less junior team members, fostering a collaborative and high-performing laboratory culture
Author and review high-quality technical reports, protocols, validation plans, and CMC sections for regulatory submissions (IND/BLA). Ensure all activities align with ICH guidelines and USP/EP compendial requirements
Collaborate with and monitor contract testing laboratories and consultants, ensuring compliance with company procedures
Perform and guide others in a variety of HPLC and Biochemistry techniques including SEC, RP, IEX SDS-PAGE, CE and icIEF to assess product quality and characterize products
Perform formulation and stability support by performing force degradation studies
Advise and support efforts for method troubleshooting remediation, change, and optimization efforts in conjunction with Quality Control
Lead support activities for the Process Development teams to characterize process improvements and develop new products
Oversee the maintenance, calibration and operation analytical equipment and instruments
Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities
Education & Experience
Ph.D. in Chemistry, Biochemistry, Molecular Biology or related scientific field with 6+ years of relevant experience in the biopharmaceutical industry required; or
MSc in Chemistry, Biochemistry, Molecular Biology or related scientific field with 9+ years of relevant experience in the biopharmaceutical industry required; or
Bachelor's degree in Chemistry, Biochemistry, Molecular Biology or related scientific field with 12+ years of relevant experience in the biopharmaceutical industry required.
Extensive experience in method development, method validation, and method transfer is required.
Previous supervisory experience strongly preferred
Knowledge, Skills, & Abilities
Expert knowledge of HPLC and Biochemistry techniques including SEC, RP, IEX SDS-PAGE, CE and icIEF
Working knowledge of biological assays including ELISA, cell-based potency assays, and flow cytometry
Familiarity with formulation development is required, hands-on experience with formulation development is highly desired
Demonstrated ability to translate complex analytical data into actionable insights for cross-functional process development, manufacturing, quality assurance and quality control teams
Self-motivated and willing to accept temporary responsibilities outside of initial job description
Excellent interpersonal, verbal and written communication skills
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Strong project management skills. Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams
Strong statistical analysis skills
Strong technical writing skills with experience reviewing and approving: SOPs, analytical test methods, qualification and validation protocols/reports, summary reports, and CMC sections of 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 sufficient equipment 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.
$150,000 (entry-level qualifications) to $165,000 (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 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
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