Hi, I’m
SAMUEL JOEL TADIKONDA
Analytical Research and Development, Manager
Hyderabad,TG
Summary
Dynamic and results-driven Analytical Leader with over 20 years of extensive experience in pharmaceutical analytical research, method development, validation, regulatory submissions, and quality systems. Expertise includes aligning laboratory operations with GMP, GLP, OQM, HSE, ISEC, and Quality Guidelines while fostering a culture of compliance, safety, and continuous improvement. Proven track record in building and mentoring high-performing teams, streamlining processes, and delivering innovative analytical solutions that expedite product development and regulatory approvals. Comprehensive hands-on proficiency spans analytical testing across various formulations, including Active Pharmaceutical Ingredients (APIs), Solid Oral Dosage Forms (OSDs), and Parenteral Liquid Injections (LIVI), complemented by a strong foundation in stability studies, technology transfers, compliance, audit readiness, CAPA management, documentation optimization, and team leadership.
Overview
25
years of professional experience
Work History
DKR Labs Pvt. Ltd.
Manager
12.2024 - Current
Job overview
- Direct the development and validation of robust analytical methods for wet chemistry and advanced instrumental techniques (ICP-MS, XRD, DSC, PSD, Wet Analysis)
- Lead and mentor a team of 22 analysts, ensuring adherence to GMP, GLP, and HSE standards
- Design and deliver structured training programs, enhancing technical capability and compliance awareness
- Streamline project execution, reducing analysis turnaround times by 60%
- Implement comprehensive quality management systems aligned with industry best practices
- Maintained professional, organized, and safe environment for employees and patrons.
- Improved safety procedures to create safe working conditions for workers.
- Planned, created, tested and deployed system life cycle methodology to produce high quality systems to meet and exceed customer expectations.
- Developed and maintained relationships with customers and suppliers through account development.
- Accomplished multiple tasks within established timeframes.
Concresco Pharma Technologies Pvt. Ltd.
Manager
08.2023 - 01.2024
Job overview
- Set up new analytical R&D laboratory from ground up, including infrastructure design, procurement, and compliance systems implementation
- Developed and implemented comprehensive SOPs in line with GMP/GLP/OQM standards, ensuring operational readiness and regulatory alignment
- Supervised and mentored a team of 12 scientists, improving operational efficiency and achieving 100% data integrity compliance
- Introduced optimized equipment utilization and preventive maintenance programs, reducing operational costs by 30%
- Developed and maintained relationships with customers and suppliers through account development.
- Accomplished multiple tasks within established timeframes.
- Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
- Implemented robust safety protocols under HSE & ISEC standards, resulting in zero safety incidents
- Procured instruments/equipment, glassware, chemicals, and consumables with optimized budget allocation
Novartis Health Care Pvt. Ltd.
Analytical Expert
12.2012 - 12.2022
Job overview
- Served as Analytical Expert for early-phase and late-phase projects from conceptualization to regulatory submissions, contributing to successful global product launches in US and European markets
- Conducted clinical kit compatibility studies and dose finalization for clinical trials, ensuring smooth execution
- Acted as Subject Matter Expert (SME) for Particle Size Determination and Stability Study Design in GLIMS platform
- Supported comprehensive instrument/equipment qualification programs in compliance with Novartis guidelines
- Collaborated with global cross-functional teams to ensure data integrity, OQM, and ISEC adherence across all projects
- Led stability study design and execution including shelf-life and retest extensions
- Successfully navigated 15+ regulatory inspections (USFDA, EMA, WHO, TGA) with zero critical findings
- Transferred 10+ analytical methods to global QC laboratories and CMOs
- Developed and optimized SOPs for analytical tests.
- Created spreadsheets and other forms of documentation to accurately record and calculate analytical results.
- Communicated analysis results to various departments and stakeholders to effectively formulate products.
- Coordinated and performed analytical tests to comply with established standards and specifications.
- Identified plans and resources required to meet project goals and objectives.
Jubilant Life Sciences
Senior Scientist
11.2007 - 12.2012
Job overview
- Led analytical method development and validation (HPLC, GC, and PSD) for APIs, OSDs, and topical formulations for regulatory submissions
- Developed and validated dissolution methods and impurity profiling protocols
- Coordinated cross-functional teams to ensure project milestones were met within established timelines
- Executed comprehensive stability testing programs and facilitated analytical method transfers to QC departments
- Documented changes during experiments, noting unexpected issues arising during research activities.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Performed accurate quantitative analysis of targeted data research, collection and report preparation.
- Conducted document review, organization and quality control of data acquisition to draw relevant conclusions and direct research activities.
Dr. Reddy's Laboratories Ltd.
Junior Manager
08.2006 - 11.2007
Job overview
- Performed dissolution testing, HPLC analysis, and method validation under strict GMP/GLP compliance standards
- Conducted routine analysis of drug substances and formulations (APIs, OSDs, LIVI)
- Led OOS/OOT investigations and supported regulatory submissions with comprehensive analytical data
- Scheduled cross-team meetings, facilitated planning, note-taking and status updates for project execution.
- Developed project statements, deliverables and timelines for project assignments that met business objectives.
- Liaised with manager to align strategic goals and objectives and to deliver program outcomes.
- Supervised day-to-day operations to meet performance, quality and service expectations.
Matrix Laboratories Ltd. (Viatris)
Senior Scientist
09.2003 - 08.2006
Job overview
- Conducted comprehensive analytical testing of drug substances using HPLC, GC, UV, and wet chemistry techniques
- Led small project teams for specific analytical assignments, ensuring timely delivery of results for client submissions
- Maintained wet lab analysis operations including titrations, viscosity measurements, and stability testing
- Conducted experiments in laboratory environment for product development purposes.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Worked as member of integrated project team in highly collaborative work environment.
- Learned new laboratory techniques and applied expertise in carrying out enhanced experiments under supervision of senior lab members.
- Followed health and safety regulations while handling dangerous or toxic substances.
Sri Chaitanya Junior College & Vikas Educational Institutions
Junior Lecturer
01.2001 - 08.2003
Job overview
- Taught Chemistry for junior and senior intermediate students with focus on practical applications
- Supervised laboratory practicals and guided students in chemistry experimental techniques
- Developed curriculum materials and provided academic mentoring to enhance student learning outcomes
- Evaluated and revised lesson plans and course content to achieve student-centered learning.
- Assessed students' progress and provided feedback to enhance learning.
- Created materials and exercises to illustrate application of course concepts.
Education
Andhra University Campus
Master of Science (M.Sc.) from Chemistry
12.2000
University Overview
Post Graduation with Honors
Hindu CollegeGuntur
Bachelor of Science from Biological Sciences And Chemistry
05-1998
Skills
- Compliance & Quality Systems
- GMP, GLP, OQM, HSE, ISEC & Novartis Compliance
- Data Integrity & Quality Management Systems
- ICH Guidelines (Q1–Q14), USP/EP/IP/JP Pharmacopoeias, ALCOA Principles
- CAPA Management, Risk Assessment, Audit Preparedness
- Analytical Testing & Method Development
- Analytical Method Development & Validation (HPLC, GC, ICP-MS, XRD, PSD, IR, UV, SOR)
- Wet Analysis: Acid Value, Hydroxyl Value, Iodine Value, Peroxide Value, Aldehyde Content
- Arsenic Content, Lead Content, Nitrogen Content, K Value, Sulphur Dioxide
- Viscosity by Rotational & Capillary Viscometers, Extraction of Mineral Oil
- Degradation Kinetics by UV, KF (volumetric & coulometric), LOD, ROI
- Instrument Qualification & Troubleshooting: HPLC, GC, ICP-MS, XRD, DSC, TGA, PSD, UV-Vis, FTIR, TLC
- Dissolution & Physical Tests: Dissolution, Disintegration, Melting Range, Foam Height
- Equipment Management: IQ/OQ/PQ, Preventive Maintenance, AMC, Calibration
- Cross-functional Leadership & Project Management
- Regulatory Submissions (US & EU Markets)
- Process Optimization & Cost Reduction
- Training & Mentorship: Advanced instrumental & wet chemical analysis
- Team Development, Resource Planning, Client Relations
Accomplishments
- Team Excellence: Led a team of 22 scientists to develop and implement new testing methods, achieving a 100% increase in data accuracy and a 50% reduction in operational costs
- Training & Development: Designed and executed comprehensive training programs that improved analyst efficiency by 35% and reduced repetitive testing requirements
- Quality Implementation: Successfully implemented OQM-driven quality systems at Novartis, ensuring global compliance and audit readiness across multiple product lines
- Safety Leadership: Spearheaded laboratory safety initiatives aligned with HSE/ISEC guidelines, resulting in sustained zero-incident performance record
- Method Development Excellence: Developed & validated 70+ analytical methods across APIs, OSDs, LIVI, POS, and semi-solid formulations
- Global Technology Transfer: Successfully transferred 10+ analytical methods to global QC laboratories and Contract Manufacturing Organizations
- Regulatory Success: Navigated 15+ regulatory inspections with zero critical findings, demonstrating exceptional compliance standards
- Process Optimization: Optimized documentation templates and processes, reducing analytical errors by 35%
- Cost Management: Implemented calibration and preventive maintenance programs achieving 20-30% cost savings in equipment management
TECHNICAL EXPERTISE
- Advanced Instrumentation: HPLC, GC, ICP-MS, XRD, DSC, TGA, PSD, UV-Vis, FTIR, TLC, Dissolution Testing
- Wet Chemistry Mastery: Titrations, KF Analysis, Acid/Hydroxyl/Iodine/Peroxide Values, Nitrogen/Arsenic/Lead Content, Viscosity Analysis, Mineral Oil Extraction
- Regulatory & Quality: GMP/GLP/OQM/HSE/ISEC Compliance, Method Development & Validation, Stability Studies, Data Integrity, CAPA Management
- Leadership Capabilities: Team Management (up to 22 scientists), Training & Development, Cross-functional Project Leadership, Resource Optimization, Client Relations
KEY METRICS & IMPACT
- Experience: 20+ years in pharmaceutical analytical research and quality
- Team Size: Successfully managed teams of up to 22 analytical professionals
- Methods Developed: 70+ validated analytical methods across multiple dosage forms
- Regulatory Success: 15+ successful inspections with zero critical findings
- Cost Optimization: Achieved 20-50% cost reductions through process improvements
- Efficiency Gains: Improved operational efficiency by 25-35% through strategic initiatives
- Safety Record: Maintained zero safety incidents through comprehensive HSE/ISEC implementation
Timeline
Manager
DKR Labs Pvt. Ltd.
12.2024 - Current
Manager
Concresco Pharma Technologies Pvt. Ltd.
08.2023 - 01.2024
Analytical Expert
Novartis Health Care Pvt. Ltd.
12.2012 - 12.2022
Senior Scientist
Jubilant Life Sciences
11.2007 - 12.2012
Junior Manager
Dr. Reddy's Laboratories Ltd.
08.2006 - 11.2007
Senior Scientist
Matrix Laboratories Ltd. (Viatris)
09.2003 - 08.2006
Junior Lecturer
Sri Chaitanya Junior College & Vikas Educational Institutions
01.2001 - 08.2003
Andhra University Campus
Master of Science (M.Sc.) from Chemistry
Hindu College
Bachelor of Science from Biological Sciences And Chemistry
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