Tech Stack

Description

You will perform and oversee routine in-process, release, and stability testing for biologic drug substances and products in a GMP QC lab. You'll lead laboratory investigations, root cause analysis, and CAPAs, while managing analytical method lifecycle activities including validation and transfer. This role requires technical leadership and compliance with regulatory expectations.

Requirements

• Bachelor's or advanced degree in Biology, Chemistry, Biochemistry, or related field
• Minimum 10 years of hands-on QC experience in a GMP biologics lab
• Deep technical proficiency with HPLC, ELISA, capillary electrophoresis, and compendial testing
• Strong background in laboratory investigations, OOS management, and CAPA implementation
• Experience with method validation aligned to ICH Q2 and US FDA regulations

Responsibilities

• Perform and review routine in-process, release, and stability testing for biologic drug substances and products
• Perform capillary electrophoresis testing (cIEF, CE-SDS) and execute analytical methods including HPLC/UPLC and ELISA
• Lead laboratory investigations (OOS, OOT, atypical results) and conduct root cause analysis with CAPAs
• Draft and oversee protocols for method validation, verification, and transfer
• Author and review SOPs, test methods, protocols, and technical reports