Drug Product Manufacturing Scientist - Advanced Therapies Manufacturing

Role: Drug Product Bioprocess Scientist supporting gene therapy manufacturing at a new advanced facility. Responsibilities: provide technical support for tech transfer, process validation, investigations, formulation, filling, packaging, visual inspection, and process improvements; develop and review technical documents; lead technical projects to optimize process control, yield, and quality; monitor process metrics and troubleshoot manufacturing issues; serve as external technical interface and support audits. Requirements: BS in Chemical/Biochemical Engineering, Chemistry, or related field; 3+ years in cGMP manufacturing with emphasis on parenteral drugs, formulation, tech transfer, and process risk assessment; experience with gene therapy, especially AAV, preferred. Additional assets: knowledge of gene therapy drug product manufacturing, solution filling equipment, serialization, and data analysis skills. Collaboration: work within cross-functional teams and support external interactions. Work setup: Full-time, based at Lebanon, Indiana, supporting startup of a state-of-the-art gene therapy manufacturing site. High-value: focus on gene therapy modalities, AAV formulations, process validation, and regulatory documentation within a GMP environment.