Jayachandran Ramalingam

Biography

 Having Worked as a team lead for process analytical team – gained in-depth knowledge on process improvement through orthogonal approaches; identification of process/product related impurities.    Besides the technical expertise, as a project co-ordinator for contract research activities demonstrated my project management capabilities. Handled a wide variety of contract analytical testing activities ranging from electrophoresis to protein sequencing.   In my role as a senior manager in USP, I was responsible for handling monograph development for therapeutic proteins and vaccines. This is to me was a challenging task as it involves transforming from the one who follows the monograph to the one who creates the monograph. This role involved identifying the critical quality attributes, analytical method development and validation, to be very brief.    In my previous role at Syngene, i was able to guide the QC department to successfully prepare for a european regulatory audit in a very short time, besides overseeing the team to cater to the stability programs and growing needs of GMP manufacturing campaigns.

Research Interest

 Specialties:    - Analytical method development and validation   - LCMS/MS   - MALDI (PMF, in-gel digestin and protein identification)   - Protein Sequencing (Edman sequencing),    -Complete Sequencing of monoclonal antibodies,    - impurity characterization in biosimilars   -Custom designed solutions for physico-chemical characterization of proteins.   -GMP compliant lab set-up   -21 CFR Part-11 compliance and computer system validation   - client management and handling regulatory queries   - Team building and mentoring