Rangeetha R Verma

Program Management Team

• Project planning to define project scope and align stakeholders.
• Served as primary point of contact for projects and monitored
• Tracked project deliverables, achieving complete adherence to project goals.
• Coordinated effectively with cross-functional teams and stakeholders, improving project communication and efficiency
• Identified and mitigated project risks, ensuring successful project completion
• Managed project databases to reflect project status and progress. Analyzed data and generated reports.
• Continuous process improvement by assessing existing internal processes and suggesting changes to enhance robustness.
• Review of project documentation to ensure completeness and accuracy before dissemination to wider team.
• Support R&D team in budget management by ensuring proper utilisation of project budgets.
• Scheduled and facilitated project specific meetings to ensure alignment with project strategies. Tracked action items and ensured project accountability mong team members.
• Engaged with external vendors to maintain productive business relationship. Identified suitable vendors based on project needs.
• Collaborated with different R&D departments and prepared business presentations and reports, providing senior management with project updates.

R&D Drug product development department

• Design and execute formulation development and process optimization experiments for protein formulations
• Conduct formulation process screening studies, process characterization and formulation characterization experiments
• Write drug product development report
• Conduct process development studies hold time study, filter selection study, tubing study and shear stress study
• Technical report writing
• Conduct filter sizing studies and filter validation studies
• Prepare Stability study protocol as per ICH guidelines and supervise sample charging on stability study and withdrawal at regular intervals
• Stability data compilation, data analysis, stability summary report preparation
• Stability data presentation using powerpoint and presentation to cross functional teams
• Review of Batch manufacturing records, process validation protocols, reports and other technical documents
• Collaborate with functional teams to ensure alignment with CMC strategies and objectives
• Working collaboratively with manufacturing team for technology transfer
• Review regulatory sections for drug product and stability study for dossier filing
• Toxicology batch stability proposal writing to QC team for conducting stability study, gathering data from cross functional team, summarizing and evaluating for providing shelf life
• Conduct process risk assessment, develop risk response strategy and mitigate the risk
• Lab Management activities (manage lab support staff and lab maintenance activities)
• Incharge of LIMS implementation in drug product development laboratory
• Coordination with LIMS vendors for correction of templates for LIMS as per the requirement.

• Planning and performing formulation development and process optimization experiments for protein formulations (Biologics) with good documentation practices
• Conducting stress stability study for quick formulation screening
• Material of construction compatibility study of drug product with contact parts (filters, tubing, and primary packaging material)
• Data compilation, interpretation and report writing
• Conducting stability real time, accelerated and stress stability study, data compilation, data analysis, report writing
• Conducting forced degradation to evaluate degradation pathways for protein formulations
• Conducting in-use study of drug product with multi use vials/cartridges and infusion vials
• Collaboration with regulatory team for regulatory section review
• Authoring of documents on eDMS (electronic Data Management System)
• Provide support to process scale up and related document review
• Collaboration with MSAT and manufacturing teams for technology transfer
• Coordination with vendors for third party services and review of the service protocols and reports
• Procurement of Innovator drug products (RLD) and other lab consumables through SAP and conducting range setting study to compare the product profile with the inhouse products

• Development of formulation process to achieve stable protein formulation
• Formulation of highly concentrated monoclonal antibody (TFF) along with in-process analytical tests, and data interpretation for developability assessment
• Writing protocols and conducting range setting study (stability study) for the innovator (RLD) and in-house drug product as per ICH guidelines, samples analysis, and updating summary sheet with suitable plots, report writing
• Planning and conducting container closure selection study (vials & PFS), forced degradation study (alkaline, basic, temperature & oxidative), Impact of pH study with data compilation, and report writing
• Conducting freeze thaw stability study for the drug substance and drug product
• In-process analytical tests to support formulation development
• Making PowerPoint presentation and presenting to the team