Analytical Development Supervisor
Listed on 2026-10-06
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
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
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.
PreferredMaster’s degree, experience in reference standard programs, statistical trend analysis, and working knowledge of GMP, QbD, and regulatory requirements.
High-Valuebiologics, polyclonal antibodies, cGMP, late-phase development, regulatory submissions, external CDMO partnerships.
Work setuplaboratory-based, no travel expected; potential supervision of junior staff as team expands.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).