Ruqayyah Ainul Bashirah

- Led MSC isolation, expansion, and cryopreservation workflows, achieving consistent batch quality and zero major deviations across operations. - Executed end-to-end GMP manufacturing activities, maintaining full regulatory compliance and supporting uninterrupted production readiness. - Ensured optimal operating conditions in cleanrooms, contributing to improved process reliability and reduced batch variability. - Drove process development, validation, and optimization, resulting in measurable gains in yield, workflow efficiency, and product consistency. - Co-authored and improved manufacturing SOPs and operational guidelines, strengthening compliance frameworks and reducing audit findings. - Enhanced equipment reliability by overseeing preventive maintenance, calibration, and troubleshooting for critical cleanroom instruments. - Managed vendor and contractor coordination, ensuring timely equipment servicing and minimizing operational downtime. - Reviewed BMRs and controlled documentation with high accuracy, improving batch release timelines and regulatory audit readiness. - Strengthened cross-functional alignment by working closely with QC & QA to meet GMP and product quality standards. - Contributed to successful NPRA and internal regulatory audits, demonstrating robust manufacturing controls and documentation practices. - Maintained uninterrupted material supply through efficient procurement, inventory tracking, and expiry monitoring for all manufacturing consumables. - Proactively identified and resolved deviations, preserving process integrity and preventing recurrence through root-cause analysis. - Supported departmental budgeting and reporting, enabling data-driven planning and resource allocation. - Executed media fill validations with QC to confirm aseptic manufacturing capability and workflow robustness. - Provided leadership continuity as Head of Department, ensuring smooth daily operations and decision-making coverage.

- Spearheaded scale-up of upstream and cell separation unit operations from 50L to 240L, ensuring successful transition from pilot to full-scale manufacturing for recombinant insulin production. - Diagnosed and resolved critical GMP deviations including agitator failure, pH and DO instability, sensor malfunction, contamination events, and mid-feed disruptions — directly preventing batch failures, production delays, and regulatory non-compliance. - Engineered and implemented Scale Down Models (SDMs) to simulate manufacturing issues and enable root cause analysis, forming the backbone for deviation closures and CAPA strategies. - Rescued high-risk production batches by restoring upstream process stability under pressure, protecting millions in potential losses, and preserving batch continuity for global insulin supply. - Conducted trend and variability analysis using statistical tools (JMP, SIMCA), driving data-driven improvements in fermentation robustness and upstream control. - Increased product content and media compatibility via targeted small-scale studies, enabling smoother technology transfer and manufacturing integration. - Standardized and revised upstream SOPs and EOPs, enhancing procedural clarity, audit readiness, and regulatory compliance in a GMP setting. - Maintained cell bank integrity and qualification workflows, ensuring traceability and reliability across all insulin production lines. - Mentored and trained trainee scientists in pilot-scale fermentation and troubleshooting methods, strengthening team capabilities, and reducing onboarding time. Impact: These studies enhanced upstream robustness and batch-to-batch consistency, directly supporting cost-effective, large-scale insulin production for export. Together, these innovations strengthened my role under this organization to provide affordable, high-quality insulin to underserved populations globally.

- Pioneered and operationalized Malaysia’s first automated COVID-19 antibody diagnostic platform, utilizing Smart Automation Line (SAL) Technology to transform manual diagnostic workflows into a fully integrated, high-throughput testing system. - Tripled daily diagnostic throughput within 48 hours, cutting turnaround time from 7 days to under 2 days, a key contribution to Malaysia’s rapid testing capacity during the height of the pandemic. - Managed end-to-end clinical sample processing, including receipt, handling, testing, and submission of over 2,500 samples to national health stakeholders, ensuring data accuracy, reliability, and timely reporting. - Oversaw full laboratory operations at the IMR–MARii COVID-19 Diagnostic Lab, including inventory control, machine calibration, and consumable management, maintaining 100% operational uptime under high-demand conditions. - Developed core lab documentation, standardizing SOPs, protocols, and data handling procedures, enabling reproducibility and future expansion of the platform. - Represented the project in stakeholder meetings, presenting clinical performance data and workflow outcomes to national research bodies, public hospitals, and government ministries, ensuring inter-agency coordination and project continuity. Impact: These projects significantly strengthened Malaysia’s national pandemic response capacity through my direct leadership in operationalizing high-throughput COVID-19 diagnostic platforms and maternal-neonatal antibody surveillance. My work enabled the rapid generation of real-world vaccine efficacy data and streamlined diagnostics, directly supporting Malaysia’s public health infrastructure, clinical decision-making, and preparedness strategies during a critical national health crisis.

Managed research activities for hydrophobically-modified nanoparticles system as an alternative system for anticancer treatment