Renija George

· Leadership & Team Management

Managed and mentored a team of 6 technical staff, including setting performance goals, development plans, and conducting regular performance reviews. Led training programs for new hires and provided ongoing mentorship to existing team members, enhancing skills in cell culture and viral vector production.

· Upstream Process Development

Spearheaded upstream process development for microbial (pDNA) viruses and cell cultures, ensuring scalable and reproducible processes for tech transfer to cGMP manufacturing. Led hands-on laboratory experiments, designing and executing multi-step projects that contributed to process optimization and product development.

· Project Management

Developed project timelines, work plans, and cost proposals, ensuring alignment with organizational goals and timelines. Managed day-to-day operations in the upstream process development laboratory, including troubleshooting and data analysis to drive continuous improvement.

· Documentation & Reporting

Authored and reviewed SOPs, manufacturing batch records, and process-related documents, ensuring accuracy, compliance, and traceability. Provided data analysis, statistical trending, and technical presentations to cross-functional teams to inform decision-making.

· Process Transfer & Tech Transfer

Coordinated successful technology transfer from bench-scale to pilot-scale and clinical manufacturing, ensuring smooth handoff to Quality Control teams. Worked closely with cross-functional teams to ensure the successful implementation of upstream processes into manufacturing environments.

· Safety and Lean Practices

Ensured compliance with environmental and safety standards in laboratory and pilot plant areas, consistently meeting safety benchmarks. Introduced Lean Production System tools to improve laboratory efficiency and process optimization.

· Developed and optimized scalable, robust, and cost-effective cell culture processesusing miniature, bench-scale, and larger disposable bioreactors for viral vector production in the laboratory.

· Provided in-plant support for cGMP manufacturingof preclinical and clinical materials, ensuring seamless transition from development to production.

· Set up, operated, and troubleshot single-use stirred-tank bioreactorsup to 200L scale, resolving technical challenges to maintain smooth process execution.

· Led upstream process R&Dfor biopharmaceuticals, including monoclonal antibodies (mAbs), immunoglobulins, vaccines (pDNA& viral), and other microbial/cell culture-derived therapies.

· Improved cGMP productionby driving clone selection, media/feed optimization, seed train development, bioreactor scale-up, and clone stability testing for efficient tech transfer to manufacturing.

· Led analytical method development projectsto enhance product quality assessment, ensuring rigorous testing and optimization protocols.

· Maintained and optimized process development equipment,recommending modifications to improve performance and operational efficiency.

· Interpreted and integrated analytical datawith cross-functional teams to refine process development plans and drive continuous improvement.

· Managed critical process data and documentation,ensuring regulatory compliance and maintaining accurate records for upstream process development activities.

· Collaborated with Downstream, QA, and QC teamsto facilitate smooth technology transfer and ensure successful implementation in manufacturing.

· Developed technical documentationincluding SOPs, reports, and data analysis; investigated deviations and led corrective actions to maintain process integrity.

· Evaluated and implemented new technologiesto advance upstream process development and maintain alignment with industry best practices.

• Led and contributed to the development of recombinant protein and plasmid production processesfrom E. coli, optimizing upstream fermentation processes to improve efficiency and productivity.
• Spearheaded scale-up and technology transfer of manufacturing processes for recombinant protein and plasmid production, ensuring smooth transition from development to full-scale production
• Designed, executed, and analyzed studies to optimize upstream fermentation processes, leveraging technical expertise to proactively identify and resolve process challenges
• Developed process design specifications and conducted studies to validate that processes met pre-determined specifications, ensuring consistent and high-quality production outcomes.
• Led experimental protocol design and execution to enhance process understanding, providing insights for continuous improvement and optimization of upstream processes.
• Represented the department on project teams, contributing technical guidance and strategic input on process optimization and troubleshooting.
• Planned and prioritized activities to align with multiple project timelines, financial goals, and personal objectives, ensuring efficient resource allocation and timely completion.
• Managed laboratory technicians and associates, overseeing day-to-day activities and providing mentorship to ensure optimal performance and adherence to project goals.
• Authored and reviewed technical documents, including SOPs, reports, protocols, and technology transfer documentation, ensuring clarity, compliance, and accurate data reporting.
• Developed and optimized robust upstream manufacturing processes based on Quality by Design (QbD) principles, ensuring processes were scalable, efficient, and compliant with industry standards.

· Led fermentation process development and improvement, including media optimization, strain development, and characterization to enhance yield, consistency, and product quality.

• Independently designed, executed, and analyzed scalable fermentation development projects using scientific and engineering principles to optimize processes.
• Kept up-to-date with industry trends by reading scientific literature, attending conferences, and participating in seminars to continuously improve manufacturing methods.
• Maintained accurate and detailed experimental records and ensured all documentation was completed in a timely manner, adhering to regulatory requirements and standard operating procedures.
• Reported research findings through development reports, presentations, and other documents to support technology transfer and project updates for cross-functional teams.
• Served as an upstream Subject Matter Expert (SME), facilitating the transfer of technology and process knowledge to internal manufacturing teams.
• Designed and managed Design of Experiments (DOE) and process characterization studies to support process optimization and troubleshooting efforts.
• Collaborated effectively with team members and clients, both in-person and remotely, to ensure successful project execution and alignment with objectives.
• Provided leadership and support to direct reports, including offering corrective actions, guidance, and motivation to achieve project goals and maintain high performance.

• Conducted benchtop experiments to evaluate fermentation process parameters across a variety of microbial strains, optimizing conditions for improved yields and efficiency.
• Prepared and processed samples using complex and standard laboratory equipment, ensuring accurate and reliable results.
• Troubleshot and resolved issues in bioreactor operations and lab equipment, ensuring smooth and efficient workflow during experiments.
• Developed expertise and became the onsite SME for various bioreactor systems, providing technical guidance and support to team members.
• Independently addressed moderately complex issues with minimal supervision, escalating more complex problems to senior staff for resolution.
• Maintained a well-organized, efficient lab environment, ensuring all equipment and supplies were properly stocked and operational.
• Performed fermentation processes using aseptic techniques to ensure contamination-free and reproducible results.
• Collaborated with and supported the cGMP team, contributing to the seamless execution of compliant, high-quality fermentation processes.

• Conducted experiments with minimal supervision to culture organisms, support program development, and produce materials for downstream processing.
• Developed protocols and documentation detailing safe operation procedures for laboratory equipment to ensure compliance and safety standards.
• Analyzed experimental data and prepared detailed reports with actionable recommendations to guide process optimization and decision-making.
• Prepared and presented experimental results in group discussions and program meetings, effectively communicating findings to stakeholders.

• Conducted fermentation experiments under supervision, supporting process development and optimization efforts.
• Drafted detailed protocols for fermentation processes, ensuring accuracy and adherence to established procedures.
• Plotted and analyzed data to assist in the preparation of technical reports and process documentation.
• Prepared purchase orders for chemicals and laboratory supplies, ensuring timely procurement for ongoing experiments.
• Managed inventory of laboratory materials and chemicals, ensuring stock levels were maintained for smooth operations.

• Processed child support cases by locating non-custodial parents, developing case information, and initiating notifications regarding obligations and enforcement actions.
• Drafted routine payment plans for support obligations and arrears, ensuring clear terms and timely implementation.
• Assisted in the preparation of child support arrearages, updating account balances, and conducting routine case updates and locates using computer systems to support enforcement efforts.
• Performed basic casework activities, including locating individuals and managing routine enforcement tasks, applying foundational knowledge of child support procedures.

• Conducted platelet counts on samples using Sysmex analyzers, ensuring accurate and timely results for clinical analysis.
• Performed quality control testing of platelet samples by conducting bacterial growth tests to assess sample integrity and safety.

• Managed guest check-in and check-out processes, ensuring a smooth and welcoming experience for hotel guests.
• Processed payments and handled reservations, accurately recording transactions and coordinating bookings.