Principal Scientist, Upstream Process Science

Principal Scientist, Upstream Process Sciences

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.

The Principal Scientist, Upstream Process Sciences role will manage the team responsible for upstream process development, process characterization, and scientific support activities for GMP manufacturing. This role serves as a technical expert for specific unit operations within the upstream manufacturing process, including both microbial and cell culture seed expansions and bioreactor operations across multiple cell lines. This role is also responsible for designing and executing process development experiments to design a robust and scalable clinical and commercial production process.

Essential Functions

• Lead and advise internal and external teams in development of efficient and robust microbial and cell culture production for whole cell products, viral vector, recombinant monoclonal antibodies, Fc-fusion, and other proteins for research, clinical, and commercial manufacturing.
• Provide high-level technical knowledge in the development of batch, fed batch, and perfusion processes for inoculum expansion and biologics production operations.
• Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance
• Provide project coordination and high-level technical expertise in process development, process improvement, scale-up, and tech transfer activities.
• Guide and advise other technical staff in risk assessment, Design of Experiments (DOE), process characterization, process validation, and process monitoring activities.
• Provide input for development programs, and collaborate with discovery, formulation, analytical, quality, regulatory and manufacturing teams.
• Draft, review and approve technical protocols, reports, and manufacturing deviation investigations.
• Present activities and results interdepartmentally, and to senior management.
• Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.
• Author and review process-related regulatory submissions.
• Conducts daily tasks associated with development and characterization of novel human therapeutics.
• Responsible for laboratory equipment maintenance programs.
• Create, edit and adhere to Standard Operating Procedures (SOPs).
• Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Education & Experience

• Ph.D. in Cell Biology, Microbiology, Biology, or other life science or related field with 6+ years of experience in biopharmaceutical-based process development and/or GMP manufacturing operations including direct experience in upstream processes required; or
• MSc in Cell Biology, Microbiology, Biology, or other life science or related field with 9+ years of experience biopharmaceutical-based process development and/or GMP manufacturing operations including direct experience in upstream processes required; or
• Bachelor's degree in Cell Biology, Microbiology, Biology, or other life science or related field with 12+ years of biopharmaceutical-based process development and/or GMP manufacturing operations including direct experience in upstream processes required.
• Previous supervisory experience strongly preferred

Knowledge, Skills, & Abilities

• Fundamental knowledge of cell and molecular biology, immunology, and/or virology
• Possess a high level of honesty and integrity, highly motivated and detail oriented.
• Expertise in developing upstream biopharmaceutical production processes.
• In-depth knowledge of statistical design of experiments (DOE) used in process development.
• Master-level technical knowledge of microbial, cell culture, and harvest operations affecting product quality.
• Working knowledge of quality systems related to process development, clinical and commercial manufacturing.
• Excellent communication skills.
• Ability to advise and collaborate with colleagues within and across departments and corporate entities.
• Familiarity with downstream purification operations.
• Adapts to rapidly changing work environment and shift in priorities.
• Possess strong written and verbal communication 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.
• This role works in both lab and cleanroom environments.
• Occasional travel may be required, up to 10%.

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 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.

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.