Associate Director, Quality Control, Biologics

Responsibilities

• Develop and implement phase-appropriate QC strategies for biologics and ADC programs
• Provide scientific, technical, and GMP oversight for QC testing and method lifecycle activities
• Oversee execution of GMP and non-GMP analytical testing for drug substance and drug product
• Lead review and interpretation of QC data, trends, OOS/OOT results, and investigations
• Manage external contract testing laboratories and CDMO QC functions
• Author and review QC-related SOPs, protocols, validation plans, and regulatory submission content
• Lead, mentor, and develop scientists and technical staff

Requirements

• Bachelor’s or advanced degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related field
• 10+ years of experience in Quality Control, Analytical Development, or CMC within biotechnology/biopharmaceutical industry
• Demonstrated experience supporting QC programs for biologics; ADC experience strongly preferred
• Proven experience with GMP release and stability testing, method transfer, and validation
• Prior experience managing CTLs, CDMOs, CROs, or other external partners
• In-depth understanding of GMP standards and global regulatory guidance
• Technical knowledge of analytical technologies such as HPLC/UPLC, CE-SDS, LC-MS, and ELISA

About the Company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, including antibody-drug conjugates (ADCs).