SINDHU KAMESHRAJ

• Manage and execute operations across various CMC and Technical areas, including Analytical development, Drug Substance, Drug Product development, Manufacturing (Technical and GMP), Supply chain, and Logistics for a range of projects.
• Lead weekly meetings to review project progress and confirm that actions are accurately recorded in the meeting minutes.
• Utilized Smartsheet to manage timelines effectively.
• Liaised with suppliers and contractors for seamless delivery of resources.
• Facilitate quarterly Material Inventory meetings to provide updates on current material status
• Tracked stability data trends through Graphpad analysis
  Involved in stability data input on CMC regulatory dossiers, including IND, IMPD.
• Maintained an organised filing system for all project documents, enhancing accessibility.
• Administered handling of clinical files on the eTMF platform.
• Manage the budget tracker for multiple projects while facilitating approval and processing Purchase Orders through the NetSuite system.

In this role I was working on developing assays to support the Clinical trial and research activities focused on AAV Gene therapy Programmes like Hemophilia A and B, Fabry and Gaucher Diseases.

I was also working clinical trial Screening assays and method development and validation of assays. While in this role I coordinated with clinical operations team from receiving the patient sample, liasing with the shipping company, storing and tracking.

• Good knowledge and understanding of GCP-ICH regulations and GCLP
• Good knowledge and understanding of Clinical trial set up..
• Worked cross-functionally.
• Supported internal and external audits by organizing the files and checking them periodically
• Trainer for less experience team member.
• Writing and updating SOP
• Deviation investigation and CAPA implementation
• Change controls where necessary.
• Reviewing of quality documentation when required.
• Tech transfer of clinical assays
• Setting up meetings internally to communicate status of the lab work.

• Performed routine cell culture to maintain adherent and suspension cell lines for various cell engineering programs (HEK293T).
• Assist with feasibility studies for potential new partnerships.
• Assist with LV(Lentiviral vector) manufacturing requirements.

• Involved in manufacturing of cell lines and completing necessary paperwork like BMR and PRQD to comply with GMP standards
• Performed quality testing of manufactured cell lines using angiogenesis assay and was involved in sterility testing
• Writing and updating SOP's relative to area of responsibility
• Deviation investigation and CAPA implementation
• Completion of quality records in accordance with company's Quality Management System and ISO13485
• Software Used: Incucyte live cell imaging platform and Angiosys

• Company Overview: National Confidential Inquiry into Suicide and Homicide by People with Mental Illness - Research project.
• Day to day data processing, eg, sending out large batches of questionnaires to clinicians, reminders, checking/ resolving any queries arising about the information received, processing of patient case notes adhering to strict protocols.
• Acting as the first point of contact for telephone inquiries regarding all Inquiry studies, providing a courteous and efficient service to external colleagues (medical and health professionals based in NHS trusts, representatives of other agencies) and internally within the Centre.
• Liaison with health staff eg medical records staff, clinical director and consultant psychiatrists in trusts concerning the timely collection of patient information, explaining Inquiry processes if required.
• Providing secretarial/administrative support more broadly within the team, eg, room booking, minute taking in research meetings.
• National Confidential Inquiry into Suicide and Homicide by People with Mental Illness - Research project.

• The study involved analyses of the coalition of cell adhesion molecules with the proliferation potency of MSC and analysis of growth curve of ADSC.
• The cell surface markers obtained during every passage is analyzed and the well-expressed passage were cryopreserved for future therapeutic application.

• Performing checks in-process sample, finished product, and ensuring the documentation is in compliance.
• Aseptic techniques, Microbiology limit test, Bacterial endotoxin test, sterility test, bioburden, purified water test, and environmental monitoring of cleanrooms.
• Raising CAPA and investigate by preparing a report.
• Participated in troubleshooting and laboratory investigations as required.
• Implemented good manufacturing practices (cGMPs and safety guidelines).
• Strong report writing skills (SOP), responsible for keeping accurate records of the lab logbook and results to be complaint with GMP regulation.
• Supporting Team leader with other laboratory activities as and when required.
• Aware of quality management standards and GMP practice.