Mohit Santilal

Leading downstream process development activities supporting in-house cGMP manufacturing of lentiviraland retroviral vectors for the commercial AUCATZYL cell therapy product.

• Led team of scientists and associates by providing mentorship, performance reviews, and career development guidance.
• Collaborated with QA, manufacturing, analytical development, supply chain, and regulatory teams to ensure project objectives were met.
• Assisted in cross-functional efforts for data integrity compliance and provided technical support for FDA, MHRA, and EMA submissions.
• Diligently managed laboratory operations, ensured safe laboratory working practises and equipment’s were serviced.
• Communicated and delivered technical presentations, project updates, and operational reports for senior stakeholders.
• Conducted cost of goods analysis and evaluated technologies to enhance product quality and operational efficiency.

Supported process development and technology transfer for CHADOX and MVA vector platforms.

• Assisted in coordinating activities between internal teams and contract manufacturing organisations (CMOs).
• Ensured work packages were completed in tight timelines.
• Aided planning project timelines and conducted cost analysis for process characterisation studies/work packages.
• Provided support during technology transfer and offered technical oversight throughout development campaigns.
• Reviewed and authored SOPs, protocols, technical reports, and GMP batch documentation.

Technical lead for lentiviral vector downstream process development and manufacturing support activities enabling GMP manufacturing scale-up to 500L.

• Defined work packages coordinated and directed external innovation collaborations/ partnerships for downstream purification technology projects to maintain GSK’s technical competitiveness.
• Acted as technical lead for CMO interactions and third-party GMP manufacturing support activities.
• Coordinated and chaired cross-functional meetings involving QA, QC, Supply Chain, Manufacturing, and Analytical Development teams.
• Took charge of authoring of CMC sections of regulatory submissions (IND/NSN) and maintained high attention to detail.
• Responsible for GMP documents technical reviews and approvals (batch records, sampling plan) and authored process development summary reports.
• Discovered and introduced novel platform technologies for resolving lentivirus processing challenges, doubled productivity/recoveries and reduced cost of goods.

Supported GMP upstream and downstream manufacturing operations for commercial lentiviral vector production contributing to Novartis Kymriah® CAR-T therapy manufacturing.

• Coordinated team activities during upstream processing operations including media preparation, cell expansion, and bioreactor operations.
• Supported process performance qualification (PPQ) campaigns and commercial manufacturing readiness.
• Authored SOPs, batch records, change controls, and deviation documentation.
• Operated chromatography systems and supported aseptic downstream purification activities.
• Collaborated effectively across manufacturing, QA, QC, and technical operations teams