Principal Scientist, Analytical Development - Process Science

About the role

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.

Responsibilities

• 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
• 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

Requirements

• 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.

Qualifications

• Expert knowledge of HPLC and Biochemistry techniques including SEC, RP, IEX SDS-PAGE, CE and icIEF
• Familiarity with biological assays including ELISA, cell-based potency assays, and flow cytometry
• Working knowledge of 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
• Excellent interpersonal, verbal and written communication skills
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• 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

Skills

• Expert knowledge of HPLC and Biochemistry techniques including SEC, RP, IEX SDS-PAGE, CE and icIEF
• Familiarity with biological assays including ELISA, cell-based potency assays, and flow cytometry
• Working knowledge of 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
• Excellent interpersonal, verbal and written communication skills
• 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

Benefits

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

Pay

The annual base pay range for this position is $150,000 (entry-level qualifications) to $165,000 (highly experienced) annually

Schedule

This position works on site, in Louisville, CO. Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.

Physical Environment

Working environment is within a GMP BSL-2 laboratory with sufficient equipment to complete the tasks described above. Occasional transportation of small equipment, frequent bending, sitting, squatting and lifting up to 40 lbs. This position is eligible for a discretionary bonus and equity award.