Analytical R&D Scientist

Sri Divya Draksharam

Jacksonville, FL +1-518-***-**** ******@**********.*** LinkedIn

Analytical R&D Scientist GxP Compliance Expert Digital Transformation SME

PROFESSIONAL SUMMARY:

Senior Pharmaceutical R&D and Compliance Professional with 13+ years of experience in analytical method development, GxP compliance, and regulatory submissions for global markets. Specialized in API, parenteral, and ophthalmic dosage forms. As a compliance manager handled various site specific key reports, OOX, Deviations Investigations and Audits. Proven success in leading digital transformation (DocFocus (Azure)) and cross-functional compliance initiatives. Recognized for analytical excellence, process innovation, and international exposure (Switzerland).

CORE COMPETENCIES:

-Analytical Method Development (HPLC, UPLC, Dissolution)

-GMP, GLP, ALCOA+, 21 CFR Part 11 Compliance

-Digital Transformation (DocFocus (Azure), Salesforce, ServiceNow )

-Product Ownership Compliance Automation Audit Readiness

-API, Parenteral, Ophthalmic & Topical Drug Products

-KPI/KQI Dashboards Validation Master Plan Data Integrity

-Stakeholder Engagement QMS Governance Lean Lab

Professional Experience: Novartis (May 2012 - June 2025)

Expert Science & Technology (GMP Compliance Manager)

Jan 2023 – June 2025

-Acted as Authorized Signatory for analytical testing and documentation; ensured compliance with global regulatory expectations and Novartis quality standards.

-Utilized specialized tools, instruments, and laboratory infrastructure; managed their qualification, calibration, and maintenance schedules.

-Led internal digital transformation as Product Owner of Azure-based lab automation platform; streamlined global workflows and enhanced data integrity across analytical sites.

-Developed and deployed Salesforce dashboards to monitor KPIs such as deviation closure, training completion, and analytical performance metrics.

-Integrated Trackwise and 1QEM with quality data tools to align with ALCOA+, 21 CFR Part 11, and GxP digital compliance requirements.

-Proactively identified and addressed project and compliance risks; collaborated across functions to implement preventive and corrective actions.

-Authored Validation Master plan, OOX Trend reports, Monthly Business Reviews, KPI Dashboards, Quality culture & Data Integrity Reports, KQI reports, SOPs, and digital lab procedures under minimal guidance.

-Audit & Inspections effectively handled by actively involved as SME, War room manager, Document manager and CAPA Owner.

-Supported function-specific sub-teams and contributed to project task execution with a focus on quality and timelines.

-Championed initiatives in Lean Lab practices, process optimization, and continuous improvement aligned with quality, environmental, and safety standards.

-Trained and mentored associate scientists, interns, and technicians in documentation, compliance, and technical protocols.

-Resolved complex scientific and compliance issues using sound judgment, adhering to company policies and professional standards.

●Contributed to department-level cost center goals by improving operational efficiency through digitalization and strategic planning.

●Innovation council member to drive innovation at site by improving Ways Of Working.

●Data privacy, Business Information Security Champion for site to create awareness, handle data breach.

●Diversity and inclusion champion for site to spread the importance of Diversity and necessity of Inclusion

Expert Science & Technology (Analytical R&D)

Oct 2021 – Dec 2022

-Independently planned, organized, and executed scientific experiments, GMP testing, and manufacturing plant-related activities with minimal supervision; managed multiple projects simultaneously.

-Directed analytical method development, validation, and release/stability testing for parenteral and ophthalmic products.

-Developed new analytical techniques and optimized existing laboratory methods to meet project timelines and quality metrics.

-Performed raw data evaluation, verification of peer-generated data, and approval of analytical results.

-Maintained documentation accuracy through meticulous raw data review, result evaluation, and approval of experimental outcomes.

-Authored technical documents including protocols, validation reports, and method transfer documents aligned with global SOPs.

-Ensured full compliance with cGMP standards, supporting regulatory inspections and internal audits.

-Actively participated in Lean Lab and innovation initiatives, contributing to new technology adoption and process enhancements.

-Maintained high laboratory safety and environmental protection standards while ensuring information security.

-Trained junior staff and coordinated cross-functional knowledge exchange in a global team setting.

-Participated in planning, execution, and completion of assigned project-related tasks under function-specific sub-teams.

Scientist - Analytical R&D (Specialty Team)

Sep 2016 – Oct 2021

-Executed analytical testing for GLP toxicology and clinical studies (Phases I–III), maintaining strict compliance with data integrity guidelines.

-Supported dossier preparation, regulatory filing activities, and document review for global submissions.

-Developed, validated, and optimized test methods for API and finished products; resolved method-related technical challenges.

-Maintained laboratory equipment, ensured calibration and qualification compliance, and reported deviations promptly.

-Conducted literature reviews, provided scientific insights for formulation and analytical strategy discussions.

-Reviewed documentation, interpreted results, and suggested next steps for method refinement and process development.

-Mentored new scientists, temporary employees, and interns in lab operations and documentation best practices.

-Authored protocols, scientific reports, SOPs, and digital lab procedures under minimal guidance.

-Supported cross-functional collaborations with QA, microbiology, and formulation units to ensure seamless tech transfer and compliance.

Associate Scientist - Analytical R&D

Dec 2013 – Aug 2016

-Performed method development and stability testing for APIs, Orals, Parenterals dosage forms in compliance with global regulatory standards.

-Documented raw data, evaluated results, and proposed experimental directions with increasing independence.

-Contributed to resolution of technical issues and collaborated with peers in data verification and report finalization.

-Managed multiple experiments concurrently, prioritizing tasks to meet development timelines and quality metrics.

-Took initiative in SOP development, training activities, and maintenance of analytical instruments.

-Participated in validation master plan execution and supported lab compliance audits and walkthroughs.

Trainee Associate Scientist – Analytical R&D

May 2012 – Nov 2013

-Assisted in analytical method development, chromatographic analysis, and documentation for development-stage pharmaceutical products.

-Performed hands-on lab testing, data recording, and experiment support under direct supervision.

-Gained experience in GMP documentation, report writing, and compliance protocols.

-Supported instrument maintenance and qualification activities.

-Deputed to Novartis Pharma AG – Basel, Switzerland, contributing to NCE analytical support and global submission readiness.

EDUCATION:

M.Pharm – Pharmaceutical Analysis

JSS University, Mysore Silver Medalist 2010 – 2012

B.Pharm

JNTU Kakinada 2006 – 2010

CERTIFICATIONS & TRAINING:

-Registered Pharmacist – Pharmacy Council of India

-Program in Pharmaceutical Medicine – Novartis

-Trained in QbD, Lean Lab, ERP Tools, Salesforce Admin Basics

TECHNICAL SKILLS:

Platforms: Azure (DocFocus) GLIMS TrackWise SFDC 1QEM Chromeleon FirstDoc Qlik Sense KPI ServiceNOW DocStore eLN (Lab NoteBook)

Instruments: HPLC, UPLC, KF, Dissolution (USP IV), Osmometer, Viscometer, Subvisible particle counter, UV, Microscopy

Compliance: US-FDA, EMA, WHO, ICH, Health Canada ALCOA+, 21 CFR Part 11

AWARDS & RECOGNITION:

- Above and Beyond Gold Award (x2) – IND Submissions

- Appreciation Award – Development Project

- Quality Feed Forward Awards (x2) – High-Quality Deliverables

- Recognized “Go-To Person” for TEDI/SUBWAY & DA Review

- Silver Medalist – Academic Excellence, JSS University

RESEARCH PROJECTS:

-Bio-Analytical Method Dev. – Cefepime & Tazobactam (RP-HPLC)

-Formulation & Evaluation – Diclofenac Matrix Tablets

INTERESTS:

Digital Quality Systems Biologics & Cell/Gene Therapy Pharma Innovation Compliance Tech Global Regulations Regulatory Affairs Investigations Analytical R&D Ophthalmics and Parentrials

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