Scientist I, Analytical Development - Process Sciences

NKW ImmunityBio; Louisville (CO); On-site; USD 110,000 - 160,000; Full time

Job summary

ImmunityBio is seeking a Scientist I, Analytical Development - Process Sciences to provide analytical support across biologics platforms and advance our pipeline. The role will perform analytical testing, method development, and method qualification/validation, with data review, technical writing, and junior team training.

Collaborating with Manufacturing, QA, QC, and Regulatory Affairs, you will contribute to regulatory filings and cross-functional projects, ensuring cGMP compliance and

Qualifications

• Bachelor's degree in a scientific discipline with 8+ years of relevant GMP/GLP Biologics or biopharmaceutical experience.
• Master's degree in scientific discipline with 6+ years of relevant GMP/GLP Biologics or biopharmaceutical experience.
• PhD in scientific discipline with industry or post-doctoral experience.

Responsibilities

• Perform analytical testing, product characterization, and method development for biologics products.
• Support method transfers, qualification, and validation.
• Author and review data, methods, SOPs, protocols, reports; support cross-functional teams.

Skills

Analytical testing

HPLC

Capillary electrophoresis

GMP/GLP experience

Data review

Technical writing

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

PhD

Tools

HPLC system

Karl Fischer

Job description

Company Overview

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.

Why ImmunityBio?

• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• 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.

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 a 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