Rukendra Kumar Singh Email & Phone Number

Bengaluru, Ka, In

Bengaluru, Karnataka, India

Biopharmacutical Development

Ahmedabad, Gujarat, India

Engaged in the development, and qualification of application of all lot-release and characterization HPLC, UPLC, and HOS-based assays across a range of diverse biologics ranging from simple peptides to complex monoclonal antibodies and peptides. These essays are integral to supporting all R&D activities; process development, process optimization, stability, analytical similarity, forced degradation, and analytical supportive studies which are critical parts of dossier submissions. My role encompasses making sure the department and the program teams have the appropriate level of scientific ability by providing oversight of the analytical data, in addition to overall team due diligence to ensure compliance with project goals anddeliverables as per organizational priorities and regulatory guidelines. I am actively involved in overseeingdevelopment initiatives and act as the function's representative on cross-functional program teams. Review studyprotocols, participate in team discussions about science and strategies, and offer advice on sampling and testing methods. Co-author/review Documents for CQA, QTPP, comparability, and analytical similarity assessmentsand query responses. Managing a team of about four (direct) with respect to technical training, coordinationfor project-related activities, overall team development, and appraisals. Track study status as appropriate, and conduct regular communication with team members, internal and external stakeholders, CROs, and outsourcedfacilities, formal and informal, regarding study status and other changes.

Ahmedabad, Gujarat, India

Projects: One early-stage (mAb) & one Late stage (peptide)Technical: Method development and qualification (validation) of analytical quality attributes for monoclonal antibodies such as purity, quantity, and charge variant/Isoforms (CEX, HIC, SEC, and ProA) and excipient/ Polysaccharide analysis, Transfer to QC (GMP) Lab as per regulatory guideline.Troubleshooting: Provide support via scientific and strategic discussions to CFT i.e., CMC, process team, QC for new and late-stage projects, Handling deviation, CAPA, OOS, OOT, and performing investigation, suggestsampling and testing strategies.Regulatory exposure Ownership of late-stage global projects, Preparation of query response, design andperform experiments for global regulatory agencies like EMA and MHRA.Author/Review: Method validation protocol, reports, CQAs, QTPP, PIN, JOS, DS comparability, analyticalsimilarity assessment, briefing book, analytical source document.Team management: Led a 5-member team to support Planning, scheduling, monitoring, and controlling &deliveries on various project timelines as the function's representative on cross-functional program teams.Identifying the risk/ issues and planning the mitigation strategies, Reviewing and trending analytical data to make sure the department has the appropriate level of scientific expertise.Analytical equipment: UPLC, UHPLC, HPLC, UV-VIS Spectrophotometer and Capillary electrophoresis PA-800& Maurice, cIEF, CD and Fluorescence spectroscopy), SOLO-VPE.Achievement: Query response for Peptide while getting marketing approval from EMA/MHRA approval and RCGM approval for mAb.Additional responsibilities: Preparation of URS for procurement of new analytical equipment, Designing thelab ensuring GxP environment, Equipment qualification CSV implementation as per regulatory guidelines.

Ahmedabad Area, India

Work as analystSpecialist in HPLP (agilent and Shimarzu), SDS-PAGE, BRADFORD, BCA, SPECTROPHOTOMETER, AND ALL BASIC TECHNIQUES USED IN ANALYTICAL

Master Of Technology - Mtech

Bachelor Of Technology (B.Tech.), Biotechnology, A

Activities and Societies: Got 1st prize in STREET painting in college fest i have done my b-tech in biotechnology stream