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 •  We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.