Lohith Kumar

Bioanalytical Program Manager @Resolian

Fordham, GB

Team Leader in the Immunoassay group.Leading a team of Scientists, Senior Scientists and Study directors responsible for the timely delivery of ADA/PK/PD services to customers Study Director /Principal Investigator/Analytical Project Manager for regulated GLP / GCP large molecule Bioanalytical studies- Validation and sample analysis of Immunogenicity, Biomarker and PK/TK studies. Mentoring scientists, SD/PI/SD within the team on the appropriate management of studies Oversee Method development scientists, provide technical support where necessary and help with troubleshooting. Managing laboratory resources (materials/reagents) to be used for a study in a cost effective manner. Reviewing of data and documents as per regulatory guidelines and SOPs and constant interaction with quality assurance team and sponsor. Effectively communicating with clients to ensure they are kept up to date with the progress of their studies and making proactive decisions wherever required. Coordinating with QA team, Analysts and other cross functional teams to ensure operational progression of studies Active member in implementation of Automation in Immunoassay department. Successfully faced several regulatory audits by FDA, MHRA, and sponsors Ensure the team provides an excellent level of communication to customers Deliver projects to agreed timelines; closely monitor/support studies from initiation to archival Maintain service area SOPs in line with the latest industry guidelines Actively work with the Business Development team in the review of client proposals Oversee the personal development of team members Scheduling projects and day-to-day management of the team. Overall financial responsibility for the revenues generated within the team. Driving a culture of continuous improvement and lean-working practices within the team Good client relationships and interact with them on regular basis to understand their needs to meet the deliverables.

Indira Gandhi National Open University

Post Graduation diploma

University of Mysore

Master of Science (M.Sc.)

London Metropolitan University

Professional certificate

CBSE, DELHI

CLASS XII

University of Mysore

Bachelor of Science (B.Sc.)

CBSE, DELHI

CLASS X