Analytical Development Supervisor

Role: Analytical Development Supervisor within the ADQC lab, focusing on biologics (polyclonal antibody) development from early to late stages, supporting regulatory submissions and commercialization. Responsibilities: lead hands-on analytical activities including method development, qualification, validation, transfer, troubleshooting, and lifecycle management; ensure analytical readiness for late-stage development and market launch; oversee reference standards, assay controls, and critical reagents; contribute to specification setting and regulatory documentation; manage lab operations, equipment, and infrastructure; collaborate with QC, QA, and external partners to maintain GMP compliance and inspection readiness. Qualifications: Bachelor's degree with 7+ years in life sciences/biotech/pharma, deep expertise in HPLC, CE-SDS, cIEF, LC-MS, and experience with method validation per ICH, FDA, USP/EP guidelines; strong scientific judgment, technical writing, and communication skills. Preferred: Master’s degree, experience in reference standard programs, statistical trend analysis, and working knowledge of GMP, QbD, and regulatory requirements. High-Value: biologics, polyclonal antibodies, cGMP, late-phase development, regulatory submissions, external CDMO partnerships. Work setup: laboratory-based, no travel expected; potential supervision of junior staff as team expands.