Specialist, Quality Control Analytical
ImmunityBio, Inc.
August 31, 2026
Full-time
On-site
El Segundo, CA
Operations
Role: The Specialist, Quality Control Analytical serves as Subject Matter Expert advising testing labs on method development, validation, transfer, and quality investigations within a biopharma setting. Responsibilities include authoring and reviewing SOPs, test methods, validation protocols, and regulatory documentation (IND, BLA), reviewing stability data and lot release CoAs, troubleshooting analytical methods, managing change controls, and supporting regulatory submissions. The role also involves technical collaboration with contract labs, data trending, and ensuring compliance with GMP, USP, EP, and ICH guidelines.
Qualifications: Bachelor’s degree + 6+ years or Master’s + 4+ years in Analytical Chemistry or related field, with experience in method development, validation, transfer, lot release testing, and stability programs. Strong technical writing, regulatory knowledge, and GMP compliance are required.
High-Value: Focus on biologics or cell/gene therapy modalities, with emphasis on analytical methods for quality control, regulatory submissions, and manufacturing support. Involves collaboration with QA, Regulatory, and external testing labs, working onsite in Southern California.
Work Setup: On-site position with standard business hours, requiring flexibility and PPE use, physical mobility, and ability to lift up to 50 pounds.
Qualifications: Bachelor’s degree + 6+ years or Master’s + 4+ years in Analytical Chemistry or related field, with experience in method development, validation, transfer, lot release testing, and stability programs. Strong technical writing, regulatory knowledge, and GMP compliance are required.
High-Value: Focus on biologics or cell/gene therapy modalities, with emphasis on analytical methods for quality control, regulatory submissions, and manufacturing support. Involves collaboration with QA, Regulatory, and external testing labs, working onsite in Southern California.
Work Setup: On-site position with standard business hours, requiring flexibility and PPE use, physical mobility, and ability to lift up to 50 pounds.