Teams at PSC Biotech Corporation

Provides Quality Assurance oversight for pharmaceutical, biotechnology, or medical-device validation documentation. Reviews and approves validation protocols, reports, risk assessments, deviations, investigations, CAPAs, and change controls. Ensures compliance with GMP, FDA, EU GMP, ICH, company procedures, and document-control requirements. Collaborates with Validation, Engineering, Manufacturing, and Quality teams to resolve deficiencies, supports audit and inspection readiness, and contributes to quality-system improvements.

Leads sterile injectable formulation development, compounding process design, technology transfer, scale-up, process characterization, and commercial manufacturing readiness. Provides technical support for aseptic filling, sterile filtration, lyophilization, engineering runs, deviations, batch investigations, and validation. Collaborates with clients, Manufacturing, Quality, Validation, Engineering, and Regulatory teams. Develops transfer plans, risk assessments, process documentation, and manufacturing instructions while ensuring compliance with FDA cGMP, EU GMP Annex 1, ICH, and USP standards.

Supports aseptic manufacturing, technology transfer, process validation, equipment qualification, lyophilization, investigations, and continuous improvement for sterile injectable CDMO operations. Leads process characterization, PPQ, media fills, contamination control, audit support, and manufacturing troubleshooting while collaborating with Quality, Validation, Facilities, Supply Chain, and client teams.