Manager, Manufacturing Science & Technology

Role: Provide technical leadership and hands-on support for sterile manufacturing operations, including Blow Fill Seal, prefilled syringe filling, sterile bag filling, and related processes. Objectives: Ensure processes are scientifically sound, validated, compliant, and continuously optimized; serve as a technical liaison across Manufacturing, QA, QC Microbiology, Engineering, Validation, Regulatory Affairs, Supply Chain, and Product Development. Responsibilities: support validation lifecycle activities, manage tech transfers and process scale-ups, lead investigations and CAPAs for deviations and contamination events, establish control strategies, collaborate on equipment qualification and process improvements, and author technical documentation. Qualifications: Bachelors in Pharmaceutical Sciences, Chemical, Mechanical, Biomedical Engineering, Microbiology, or related field; 5+ years in pharmaceutical manufacturing, sterile operations, and process validation; 3+ years in sterile manufacturing modalities like BFS, prefilled syringes, and aseptic filling; experience with FDA/EMA audits, process control, and data analysis tools. Skills: strong technical judgment in sterile manufacturing, troubleshooting, data analysis, and cross-functional influence; excellent communication and documentation skills; ability to prioritize in GMP environment. High-Value Details: emphasis on aseptic processing, contamination control, validation, and regulatory compliance; requires OSHA respirator fit test. Location: unspecified, likely on-site given GMP and contamination control focus.