Technology Transfer Specialist

Key Responsibilities

• Execute technology transfer plans by supporting end-to-end technology transfer for sterile injectable products (solutions, suspensions) from various sites.
• Ensure process parameters, critical quality attributes (CQAs), and critical process parameters (CPPs) are defined, controlled, and monitored.
• Support process risk assessments (FMEA) related to sterile manufacturing.
• Support process characterization, engineering runs, and performance qualification batches.
• Translate process development knowledge into manufacturing control strategies and batch records.
• Career controls for new and existing processes.
• Support validation for aseptic processing, sterile filtration, filling, and container closure systems (including filter validation and container closure integrity testing).
• Author and/or execute process performance protocols, reports, and change assessments.
• Identify opportunities to improve process robustness, yield, and cycle time.
• Ensure data integrity and documentation practices consistent with ALCOA+ principles.
• Support monitoring performance metrics and driving continuous improvement initiatives.

Basic Qualifications

• AS, BS, and/or minimum 2+ years equivalent experience in a pharmaceutical related discipline.
• A minimum 1 year of related working experience in sterile parenteral manufacturing is required.
• Experience working in cGMP environments that meet FDA, EMA, ICH guidelines, local regulations, and industry best practices is preferred.
• General knowledge of the pharmaceutical industry, brand and/or generics is preferred.