Manikandan Duraikannu Ph.D.,

Leadership Experience.

- Supervised a team of 10 pharmaceutical scientists as Team Lead, Quality Control Department.

- Managed laboratory operations, including procurement, vendor management, and cross-functional team collaboration.

Quality Control Expertise

-Coordinated efforts between internal departments such as manufacturing, engineering, marketing, when necessary.

- Investigated customer complaints concerning product quality issues by performing detailed root cause analyses using analytical techniques such as LC-mass spectrometry.

-Researched literature sources for information relating to current developments in the field of chemistry.

-Analyzed samples using chromatography, spectroscopy, and other analytical techniques.

-Ensured compliance with GMP and GLP guidelines.

- Managed system documents and conducted investigations.

- Evaluated raw materials for suitability in product formulations.

- Ensured compliance with regulatory agencies and safety requirements.

Pharmaceutical Analysis and Testing

- Conducted stability testing, routine analysis, and dissolution studies using HPLC, UPLC, and UV spectrophotometry.

- Performed established experiments independently.

Investigations and Troubleshooting

Conducted thorough investigations related to various pharmaceutical tests, including:

- Dissolution testing

- Assay testing

- Related substance testing

- Particle size analysis

- Water analysis

- Raw materials testing.

Utilized a range of advanced analytical instruments, including:

- High-Performance Liquid Chromatography (HPLC)

- Gas Chromatography (GC)

- Particle Size Analyzers

- Karl Fischer (KF) Auto Titrators

These investigations aimed to identify and resolve issues, ensuring compliance with regulatory standards, and quality control requirements.

Collaboration and teamwork.

- Collaborated with cross-functional teams to develop innovative solutions.

- Coordinated with manufacturing personnel to transfer technology.

Laboratory Management

- Enhanced laboratory efficiency with streamlined processes and optimized equipment utilization.

- Maintained a clean, organized laboratory.

Technical Expertise

- Performed techniques such as HPLC on assays, related substances, and dissolution testing.

- Analyzed and interpreted laboratory data.

- Developed new testing methodologies.

Leadership and Training.

- Mentored junior chemists, fostering a collaborative work environment.

- Led safety training initiatives.

Documentation and communication.

- Prepared and reviewed documentation and SOPs.

- Authored technical reports, effectively communicating key findings.

Problem-Solving and Troubleshooting.

- Troubleshoot analytical issues, identifying root causes, and implementing corrective actions.

- Modified and adapted standard methods and procedures.

Pharmaceutical Quality Control Expert

Technical Expertise

- Conducted testing and analysis of pharmaceutical raw materials using HPLC and other analytical instruments to determine parameters such as assay, dissolution, impurities, related substances, and residual solvents.

- Developed and validated analytical methods for various dosage forms using modern instruments, like HPLC, UPLC, and UV Spectrophotometer.

- Proficient in working with software associated with these instruments.

Pharmaceutical Analysis and Testing

- Conducted stability testing, routine analysis of pharmaceutical dosage forms, and dissolution studies using HPLC, UPLC, and UV spectrophotometry.

- Performed established experiments independently.

Quality Management and Compliance.

- Knowledgeable about GMP and GLP guidelines.

- Managed system documents (Deviations, CAPA, OOS, OOT, LIR), and conducted investigations.

Leadership Experience

Supervised a team of 10 pharmaceutical scientists as the Team Lead in the Quality Control Department.

- Managed comprehensive laboratory operations, including procurement, vendor management, cross-functional team collaboration, and leadership.

Documentation and Compliance.

- Prepared SOPs related to instruments and analytical activities.

- Reviewed and documented raw data according to regulatory guidelines.

Analytical Expertise
- Provided analytical support for variation dosage forms during development stage, including:
- Preformulation studies
- Routine developmental testing of drug products
- Raw data review and interpretation
- Dissolution and assay method development for solid oral dosage forms
- Stability studies as per ICH guidelines
Leadership and Team Management
- Set clear team goals, delegated tasks, and set deadlines to ensure timely completion of projects.
- Mentored junior team members, providing guidance and support to enhance their skills and productivity.
- Coordinated with project management teams to ensure the timely completion of allocated analytical projects.
Cross-Functional Collaboration

- Worked effectively with cross-functional teams, including QA, Microbiology, and SCM, to ensure the timely completion of assigned projects.
Communication and Reporting

- Produced weekly, daily, and monthly activity reports and forecasts to stakeholders.
- Assisted in recruitment efforts to build a high-performing team.

Analytical Support and Leadership Experience
Analytical Support
- Provided analytical support for various pharmaceutical dosage forms, including tablets and capsules, for numerous customer projects.
- Collaborated with top pharmaceutical companies globally, such as Janssen, Sun Pharma (SPARC), Novartis, GSK, and others.
Leadership and Team Management
- Set performance expectations, monitored progress, and provided constructive feedback to team members.
- Empowered team members by delegating responsibilities according to individual strengths and expertise.
- Managed conflict resolution, fostering a positive, and collaborative work environment.
- Maintained an inclusive and diverse team culture, promoting respect and understanding.
Strategic Collaboration and Planning
- Collaborated with other department leaders to establish shared goals and ensure alignment across teams.
- Enhanced team productivity by implementing efficient work processes and reviewing performance metrics.
Customer Satisfaction and Project Management
- Increased customer satisfaction ratings by monitoring service quality standards and addressing issues promptly.
- Led cross-functional teams to execute projects on time, within budget, and with high-quality outcomes.

Analytical and Quality Control Expertise
Analytical Testing and Validation
- Conducted drug product dissolution testing, assay testing and Organic Impuritites testing.
- Performed analytical method validation
- Executed cleaning validation analysis
- Prepared SOPs for various analytical instruments
Method Development and Stability Analysis
- Developed analytical methods for quantifying drugs in drug products
- Conducted stability analysis of pharmaceutical drug products
Quality Control and Reporting
- Generated finished release COAs, in-process COAs, and stability reports
Collaboration and Process Improvement
- Collaborated with cross-functional teams to identify process improvement opportunities
- Improved internal knowledge sharing through comprehensive documentation and SOPs
Communication and Team Collaboration
- Enhanced team collaboration through clear communication of complex findings
- Utilized visualizations and reports to facilitate understanding