Senior Scientist, Biologics Analytical R&D (On-site)

Role: Senior Scientist supporting GMP biologics analytical development and commercialization, focusing on method validation, transfer, and lifecycle management for biologics products. Responsibilities: lead analytical method validation and transfer; act as subject matter expert; interpret data, support investigations, deviations, and GMP release testing; contribute to regulatory submissions, product launches, and technical troubleshooting; ensure compliance with cGMP, data integrity, and regulatory standards; collaborate with cross-functional teams including Analytical Development, Quality Assurance, CMC Regulatory Affairs, and external partners; support audits and inspections; manage project timelines and deliverables. Qualifications: Ph.D. in Chemistry, Biochemistry, or related field with ≥2 years of GMP experience, or Master's with ≥3 years, or Bachelor's with ≥7 years. Skills include expertise in separation-based analytical methods (HPLC, UPLC, CE, iCIEF), GMP compliance, technical writing, and project management. Preferred: experience supporting GMP release, stability, and in-process testing for biologics, familiarity with LIMS, Empower, regulatory guidance (FDA, ICH, USP), and involvement in biologics late-stage development or product launch. Work setup: onsite in North Wales, PA, with approximately 10% travel.