ImmunityBio

ImmunityBio

Principal Scientist, Analytical Development - Process Science

Louisville, CO · Principal · Contract

Sponsorship not specifiedDetected 11 days ago
StatisticsProject ManagementGMPFDA RegulatoryFlow CytometryMolecular BiologyMass SpectrometryProtein AnalysisCommunicationMentoringWritingRegulatory Affairs

About the role

  • 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.

Responsibilities

  • 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.
  • 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 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.
  • Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance
  • Collaborate with and monitor contract testing laboratories and consultants, ensuring compliance with company procedures
  • 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
  • Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities

Requirements

  • Ph.D. in Chemistry, Biochemistry, Molecular Biology or related scientific field with 6+ years of relevant experience in the biopharmaceutical industry required
  • MSc in Chemistry, Biochemistry, Molecular Biology or related scientific field with 9+ years of relevant experience in the biopharmaceutical industry required
  • 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.
  • 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

Nice to have

  • 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.
  • This includes chromatography, electrophoresis, and cell-based or binding bioassays
  • 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

Skills

  • 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%.
  • Knowledge, Skills, & Abilities
  • Excellent interpersonal, verbal and written communication skills

Compensation

  • The annual base pay range for this position is below.

Benefits

  • Health and Financial Wellness Programs
  • 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
  • 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.

Company info

  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Visa & Work Authorization

  • 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
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This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.