Nilesh Thever

Project: Protein Engineering LIMS for a UK based MNC

• Collaborated closely with stakeholders to identify opportunities for process improvements and drive continuous innovation in the organization.
• Performed gap analysis to identify areas of improvement.
• Surveyed clients to ascertain requirements and expectations for product.
• Implemented best-practice methodologies that improved overall project delivery timelines while maintaining quality standards.
• Evaluate efficiency of controls and other documentations to identify risks and non-conformity issues.
• Prioritize work within agile team and maintain backlogs.

Project: Regulatory Information Management -PRC, GRAAS

• Worked as a Liaison with Authors and Global Clinical Trial Managers to work in compliance with Global Submissions and Management of Regulatory Information Requirement.
• supported numerous Health authority inspections like FDA, MHRA etc by maintaining traceable documentation and providing auditable view of essential documents.

Project: eTMF for a US based Biopharmaceutical MNC

• responsible for end-to-end TMF deliverables from archiving electronic records, perform quality checks, retrieve the records from the document management systems thus reviewing all activities in timely manner, completeness and making it inspection ready.
• Experience in document management enterprise platforms like EPIC, Veeva Vault.

• Performed Complex data entry into electronic health record systems about patients' clinical trials and streamline and share data across multiple platforms by collaborating with stakeholders to help them support clinical trials majorly in Oncology and Cardio therapeutic areas.

Design & synthesis of various biologically active molecules and derivatives using organic synthetic reactions to prepare scaffolds, amino acid couplings, suzuki, boronic acid and silanol chemistry, controlled compounds having tumor inhibiting effect etc.

• Researched patents, literature and scientific information in databases.
• Collaborated with Invitro vivo teams on product development projects by giving the synthesized biologically active molecules for experimentation.
• analytical techniques (NMR, GC-MS, LC-MS)