Teams at PSC Biotech Corporation

Provides technical leadership for pharmaceutical process development and manufacturing projects in a GMP-regulated environment. Defines process requirements, supports equipment and system design, technology transfer, commissioning, qualification, validation, risk assessments, troubleshooting, investigations, and continuous improvement. Partners with project, operations, quality, and engineering teams to ensure compliant process integration and operational readiness. Authors and executes validation documentation, develops SOPs and CQV protocols, and supports manufacturing technologies including pre-filled syringes, vial filling, sterile filtration, bulk product, NPI, and plasma manufacturing.

Provides Quality Assurance oversight for pharmaceutical, biotechnology, medical device, and regulated-industry projects. Reviews GMP documentation, supports commissioning, qualification, validation, technology transfer, process lifecycle, vendor qualification, and capital projects. Manages deviations, investigations, change controls, CAPAs, risk assessments, audits, and inspections while ensuring cGMP, GxP, and global regulatory compliance.

Leads regional business operations, business development, consulting proposals, employee hiring and performance management, and billable project execution. Provides technical expertise in equipment and process validation, maintains project profitability, develops client relationships within the life sciences industry, and supports regional growth across Australia. Requires substantial biotech experience, strong leadership and project management capabilities, and travel up to 25%.