Peter Saira

Batch Release Senior Specialist @Johnson & Johnson Innovative Medicine

Titusville, NJ, US

Maintained oversight of individual production batches, tracked deviations, and communicated status and target release timelines clearly to stakeholders.• Conducted thorough review of External manufacturer batch documentation to ensure compliance with cGMP, company standards, chain of identity, chain of custody, and product specifications.• Supported cell therapy-specific batch release processes, applying specialized knowledge of cell therapy manufacturing and release requirements.• Managed relationship with Contract Manufacturing Organization (CMO) to ensure quality oversight and consistent compliance.• Supported site readiness and responses during regulatory inspections, providing documentation and subject-matter expertise.• Authored, revised, reviewed, and approved Quality System documents including SOPs and work instructions to maintain regulatory compliance.• Applied FDA and international regulatory requirements to daily operations and decision-making across quality functions.• Monitored quality trends, identified risks, troubleshot issues, and escalated critical items to senior management.• Collaborated with Operations, Planning, Technical Operations, Medical Affairs, and Vein-to-Vein teams to support supply chain continuity and meet patient supply requirements.• Assessed existing quality systems and recommended process improvements to enhance product quality and reduce cycle time.• Led cross-functional teams to achieve quality and release objectives, promoting alignment and timely decision-making.• Performed detailed batch record reviews and release processes, ensuring documentation integrity and traceability.• Utilized process excellence tools and methodologies to streamline workflows, reduce risk, and improve operational efficiency.

University of Pennsylvania

Master's degree, Biotechnology

Peterhouse

High School Graduate

Drexel University

BSc Biological Sciences, Orginismal Physiology