S K Chandrasekhar

• Results-driven professional with over 22 years of extensive experience in analytical research and development. Demonstrated expertise in various roles including Analytical Scientist, Analytical Expert, Team Lead, and Analytical Project Leader, with a proven track record of delivering impactful results across diverse projects.
• Results-oriented Analytical Project Manager with +3 years of experience in leading and optimizing complex projects within the pharmaceutical industry at Novartis. Expertise in leveraging data-driven insights and advanced analytics to drive project success, enhance decision-making, and optimize resource utilization. Proven ability to manage cross-functional teams, navigate regulatory requirements, and deliver high-impact projects aligned with organizational goals and industry standards.
• Accomplished Team Lead with over 2 years of experience at Novartis, specializing in leading high-performing teams to drive innovation and excellence in pharmaceutical research and development. Adept at fostering a collaborative and results-oriented environment, overseeing complex projects from inception to completion, and ensuring alignment with strategic objectives. Proven track record in managing cross-functional teams, optimizing workflows, and delivering high-quality outcomes in compliance with industry standards and regulatory requirements.

Novartis health care Pvt. Ltd., Hyderabad|Dec 2013-Current

Analytical project leader:

• Responsible for developing and driving the analytical project strategy for drug substance and drug product on parenteral development: leading and managing all analytical activities within a global project team, defining analytical project plans and support for regulatory submissions.
• Successful project delivery to key stakeholders through effective management of cross-functional teams: in terms of budgets and resource allocation, and for delivery of analytical packages, against quality and timeline requirements.
• Leader of strategic innovation project: delivering significant efficiency gains in setting shelf life for clinical and commercial products. Technical & scientific leader by proactively identifying scientific, technological & GxP gaps, proposing creative solutions.

Analytical expert: 

• Provided the projects on time for IND/IMPD submission, clinical trials and Phase III registration, NDA submission and extend the support for launching at commercial sites.
• Executed variant selection stability, technical stability, clinical stability and registration stability for the global filings (Stability Study Plan, Stability Protocol, Conduct of Studies, Stability Study Report) with assessment, retest/shelf life establishment etc.
• Completed all the required analytical registration documents e.g., development/registration stability report with proposed retest/shelf life, justification of specifications, test methods, qualification documents for impurities/solvents/genotoxic impurities, toxicology report, validation summaries etc.
• Preparing and reviewing SOP’s and guidelines in accordance with cGMP
• Engaged in budgets/Capex allotments and PO’s for third party labs
• Coordinated with internal and external customers for the timely deliverables like Formulation, Regulatory Affairs, Quality Assurance, Chemical Synthetic Lab and Preclinical Safety for toxicological assessment.
• Reviewed and approved:Clinical stability study protocol, Registration stability protocol in Technical electronic documentation system and in Global Laboratory Information Management System (GLIMS), Development stability report, registration stability report, and summary of stability study report in Technical Electronic Documentation System and Global Laboratory Information Management System.

Team lead role:

• Lead a team of [number] professionals, providing mentorship, guidance, and support to achieve team objectives and exceed performance targets.
• Conducted regular performance reviews, providing constructive feedback and facilitating professional development opportunities.
• Managed project timelines and resources effectively, ensuring timely delivery of [projects/products] within budget constraints.
• Fostered a collaborative team environment, enhancing communication and resolving conflicts to maintain high morale and productivity.
• Developed training programs and resources to enhance team skills and performance, contributing to achieve maximum number of IND/IMPD submission and KQI

Dr. Reddy's Laboratories:

• Managing analytical method development and method validation for drug substances and oral drug products according to ICH, Pharmacopeia (EP, USP, JP) and country specific regulatory requirements for both Generics (US, Europe, Canada and Emerging markets) and IR, DR, ER formulations using various dissolution Apparatus (USP-1, USP-2 and USP-4).
• Drug products by analytical QbD approach for Related substances, Assay, UOD, CU by using HPLC/UPLC, UV techniques and Residual Solvents by GC Executing pre-formulation studies for drug and excipient interactions for their suitability for formulation selection and finalization Conducting Dose dumping studies for OSD products Training & mentoring team to update the latest technical upgradationsInvestigating OOE and OOS results and deviations Reviewing the stability protocols & reports and analytical methods & specifications Leading efforts in filling of dossier in key emerging markets geographies like Russia, Brazil, Delivering analytical support to Global Regulatory queries (Deficiency management) to OSD, Injectable and Topical Filings Preparing analytical method validation protocols & reports as per ICH (Q2) & USP guidelines.
• Providing analytical support to new product launch for Global launches Updating analytical procedures according to Pharmacopeia changes & updates Devising long term and accelerated stability study analysis for formulation development batches Isolating & identifying unknown impurities formed during the stability period Coordinating with cross-functional teams DQA, FRD, Plant QA, SCM, RA, ASAT and QC for analytical activities.

Aurobindo pharma:

Extensive experience in analytical method validation for drug substance and drug products of oral dosage forms.