Scientist I, Analytical Development - Process Sciences

Position Summary

The Scientist I, Analytical Development - Process Sciences will provide analytical support across ImmunityBio's biologics platforms to advance our pipeline. The role is responsible for analytical testing, method development, and method qualification/validation in support of process development activities. The role will also assist in data review, technical writing, and training of junior team members. Alongside Process Sciences and Analytical Development (AD), the role supports AD management and Regulatory Affairs with regulatory filings and will require cross-functional interactions with Manufacturing, Quality Assurance, Quality Control, and Process/Product Development teams.

Essential Functions

• Perform analytical testing, product characterization, and method development for various biologics products, especially proteins.
• Support internal and external method transfers, method qualification, and method validation.
• Author and review data, analytical methods, SOPs, protocols, and reports.
• Support Process Development to characterize process improvements and develop new products.
• Oversee the training and development of junior associates/specialists as the team grows.
• Maintain, calibrate, and operate analytical equipment and instruments.
• Interface with other departments (e.g., QC, Manufacturing, Engineering, QA and Regulatory) to ensure achievement of ImmunityBio's goals.
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor's degree in a scientific discipline with 8+ years of relevant experience in a GMP or GLP regulated Biologics or biopharmaceutical environment required; or Master's degree in scientific discipline with 6+ years of relevant experience in a GMP or GLP regulated Biologics or biopharmaceutical environment required; or PhD in scientific discipline with relevant industry or post-doctoral academic experience required.
• Hands-on experience with high-performance liquid chromatography (HPLC) or capillary electrophoresis (CE-SDS, ic-IEF) required.
• Hands-on experience with osmolality, pH, conductivity, UV-Vis, Karl-Fischer, and other analytical techniques preferred.
• Experience with protein characterization and analytical method development strongly preferred.
• Experience with method qualification, method validation, or method transfer preferred.

Knowledge, Skills, & Abilities

• Working knowledge of cGMP, and ability to adhere to pharmaceutical regulations (21 CFR 210/211, USP, EP and ICH guidelines).
• Ability to collaborate with contract testing laboratories, consultants, ensuring compliance with company procedures.
• Knowledge of formulation development, statistical analysis, mass spectrometry, and biophysics.
• Knowledge of analytical chemistry and chromatography, cell and molecular biology, immunology, and/or virology.
• Adept at instrumentation trouble shooting.
• Strong verbal and written communication skills, with technical writing experience preparing SOPs, analytical test reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA regulatory filings.
• Problem solving skills with attention to detail.
• Strong time management skills.
• Highly motivated and able to excel in a fast-moving environment.
• Team player who is capable of identifying creative solutions and has a genuine interest in establishing/expanding analytical workflows and capabilities.

Working Environment / Physical Environment

This position works on site, in Louisville, CO as noted in the offer letter. 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 equipment sufficient to complete the tasks described above. Travel up to 10%. Occasionally: transporting small equipment, frequent bending, sitting, squatting and lifting up to 40 lbs.