Anju Nair

- Served as primary liaison and subject matter expert for operational activities involving CROs, clinical sites, and central and specialty laboratories, ensuring biospecimen collection, tracking, analysis, and final disposition in compliance with SOPs, ICH/GxP, GLP/GDP, and regulatory guidelines. - Acted as business owner for biospecimen management platforms, partnering with IT teams to evaluate, implement, and maintain specimen tracking systems; led system enhancements to improve data quality, transparency, and automation. - Designed and executed specimen routing plans and workflows to support ingestion of vendor inventory into specimen management systems, aligning processes with study protocols and regulatory requirements. - Led development and enforcement of specimen meta-data standards across internal teams and external partners, ensuring consistency and accuracy of biospecimen records. - Oversaw strategic vendor selection, onboarding, and management, including scope development, contract negotiation, performance monitoring, and resolution of operational and data quality issues. - Championed continuous improvement initiatives to streamline biospecimen processes, including automation of data reconciliation and standardization of key specimen meta data across laboratories. - Lead design, execution, and interpretation of safety pharmacology and toxicology studies, ensuring high-quality, reliable data generation. - Authored and reviewed nonclinical sections of regulatory submissions (e.g., IBs, INDs, CTAs, annual reports, briefing documents) as well as responses to information requests. - Lead budget planning for the Nonclinical Department as well as Project/Vendor/CROs and manage spending within corporate guidance.

- Led operational planning and execution of biospecimen management activities across multiple clinical studies, including protocol and informed consent development, central lab database design, and logistical planning. - Developed and maintained detailed specimen trackers and routing plans, ensuring accurate reconciliation of vendor inventories and alignment with specimen management plans. - Acted as an escalation point for data quality and sample discrepancies, driving resolution of issues in partnership with vendors and internal teams. - Collaborated with IT and data management teams to support specimen data integrations, in-stream review, and QC of records from central and third-party laboratories. - Authored procedure manuals, lab flowcharts, and sample handling guidelines to standardize biospecimen processes across studies. - Supported continuous improvement initiatives, including optimization of workflows and adoption of automation tools to enhance specimen data accuracy and operational efficiency. - Participated in vendor performance monitoring and contributed to strategic development of laboratory partnerships to ensure consistent delivery of high-quality data. - Worked closely with clinical operations and medical monitoring teams to oversee specimen logistics, data review, and report for DSMB and regulatory submissions. - Led processes related to in-stream review and QC of data from central and 3rd party labs.

- Develop and optimize methods and author SOPs for sandwich and competitive ELISA. - Evaluate new therapeutic candidates and reagents through in vivo models. - Extensive experience with carotid artery catheterization, intraduodenal injections in rats for the purpose of administering test reagents and blood collection. - Part of project team involved with tech transfer of bioanalytical methods from client. - Maintain accurate records of ongoing projects in adherence with documentation standards. Contribute to technical reports, manuscripts or regulatory updates. - Maintain GLP and GMP compliance. - Participate in non-technical activities, e.g. safety, compliance, documentation, lab supply monitoring.

- Perform a broad range of biological tests by applying various in vitro assays: ELISA, cytotoxicity (MTT and MTS), FACS Analysis, CDC and ADCC assays, Immunohistochemistry (IHC), TUNEL, and Soft-agar assays. - Analyse and interpret assay results by independently designing spreadsheets and performing calculations. - Extensive experience with small animal handling and administrations of compounds via IV, IP, SC and IM delivery in mice, rats and rabbits. - Hands-on experience with small animal anesthesia. - Dissection and organ collection of mice for the determination of the pharmacodynamics/ pharmacokinetics of various injected reagents including radioisotopes (biodistribution studies). - Daily observations of animals and weekly/bi-weekly body weight and tumor measurements (therapeutic efficacy studies). - Setting up studies including the distribution of animals into appropriate treatment groups (either according to whole body weights or tumor volumes) following appropriate study protocol. - Growth and maintenance of various cell lines in vitro for the purpose of setting up animal disease models by implanting cells for tumor growth and for in vitro experiments. - Lead the team involved with preclinical research by training them in basic laboratory practice as well as in ongoing in vivo and in vitro projects. - Responsible for collaborating closely with research associates and scientists inside/outside of preclinical department and animal facility manager to promote seamless communication and ensure timely completion of projects. - Prepare and present reports to the Director of Pre-Clinical Development or at group meetings to update management and peers. - Manage multiple in vitro and in vivo projects simultaneously and meet project timelines. - Meticulous recording of data into notebooks in adherence with documentation standards and appropriately design spreadsheets.