Dinesh Chaudhari
Taichung City, Taiwan
Summary
Over 24 years of professional experience in analytical development, AS&T and QC processes for diverse pharmaceutical products.
Spearheaded CMC studies, analytical development, analytical validation and transfer and QC activities for new drug products across the US, EU, ANVISA, Japan and ROW markets regulation.
Managing a team of over 30 members to ensure on-time and on-budget project delivery.
Analytical method product life cycle management at AS&T, QC, CMO, and CDMO.
Ensuring compliance with cGxP, GLP, QMS, RCA, CAPA, and AS&T/QC processes, and timely project delivery, facilitating successful product launches in global markets.
Seasoned Senior Manager with a deep understanding of strategic business planning and development. Strengths include strong leadership, effective communication skills, decision-making abilities and problem-solving capabilities. Have consistently delivered results in previous roles by driving operational efficiency, enhancing team productivity and implementing innovative management strategies.
Responsible for multiple analytical project management tasks, I achieved significant cost savings through lab process enhancements, improving operational efficiency. Strategic team lead, guidance and technical support for NDA/ANDA submissions.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Senior Manager–Analytical Development/CMC GMP Lab
LOTUS Pharmaceuticals Ltd (ALVOGEN company)
Nantou
01.2019 - Current
- Lead and manage laboratory functions for the direction and oversight of the analytical project of ARD, AS&T, and QC projects, with a team of over 30 professionals.
- Ensure the completion of analytical method development/optimization, analytical method validation/verification packages, analytical method transfer, analytical CMC studies, and in-vitro studies, as applicable for U.S., EU, Latam, Japan, and ROW regulations.
- Supports in analytical investigations, validation, remediation, transfer, and implementation of analytical methods.
- Works cross-functionally with QC, MS&T (Manufacturing Sciences and Technology), and other relevant functions to ensure the success of assigned projects.
- Lead to ensure and monitor Pilot and Pivotal batches analysis, pre-approval stability studies, and laboratory compliance with GLP, GMP, and EHS perspective.
- Lead and ensure cGxP standards are implemented and maintained in the AS&T and QC laboratory. Collaboration in GxP audits, inspections, Quality Management Systems (QMS), and Root Cause Analysis (RCA).
- Analytical expert to support various NDA, ANDA, and 505(b)(2) projects starting from initiation to commercialization stages. Acumen for troubleshooting of undertaken activities.
- Well-versed in the implementation of B2B projects and market extension, contributing to the company's goals of 'First-to-File' and 'First-to-Market' projects for U.S. and global markets.
- Provide strategic direction, and be responsible for the pharmaceutical analytical CMC and AS&T work, with the latest global trends and concepts.
- Lead to establish an analytical lab and select proper analytical instruments, or select a CMO lab for various dosage forms.
- Lead and ensure technical collaboration with the CMO lab and outsourcing lab for the completion of analytical project milestones.
- Identify and address technical risk in analytical aspects in collaboration with R&D, AS&T, QC lab, and CMO lab for the implementation of a mitigation strategy.
- Act as an AS&T lead with QC and CMOs to design and implement improvements in analytical methods, and successful method transfer.
- Responsible for ensuring all analytical testing activities are in compliance with applicable compendia, and FDA/ICH regulatory guidance.
- Develop SOPs and quality assurance systemic documents for analytical development tasks and quality assurance; ensure all instruments are qualified in good condition to conduct analytical activities, and meet the requirements of GMP and appropriate regulatory guidelines.
- Identify, evaluate, and implement new analytical methods and quality control strategies for new product introduction at the site.
- Provide scientific guidance on complex manufacturing investigations and the resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results, and ensure data integrity.
- Work as an advisor with global PMs and other professional individuals in the sub-companies of the parent company. Provide the strategic guidance for analytical activities as needed.
- Interface with key partners includes R&D leaders, AS&T and QC leaders, CMC leaders, supply chain platform leaders, Quality Assurance, Global Regulatory Affairs, and B2B clients.
- Act as a partner with internal and external manufacturing and quality teams to ensure that appropriate analytical methods are developed, qualified, and put into use for routine QC testing and characterization of drug products, starting materials, and in-process samples.
- Thorough knowledge of Good Manufacturing Practices. Acts as area management for SOPs, change controls, deviations, and CAPAs (Corrective and Preventive Actions).
- Co-ordination in providing the analytical support to formulation development and product/process validation activities.
- Liaise with formulation development, regulatory, materials management, and other functional areas to meet project and team objectives.
- Responsible for analytical issues of deficient letters (DLs), customer complaints, change controls (CCRs), and OOS/OOE investigations.
- Participated in recruitment initiatives by interviewing potential candidates and selecting suitable hires.
- Analyzed data from market research surveys to identify trends and develop actionable insights for organizational growth.
- Developed and implemented strategies to improve operational efficiency, reduce costs, and increase productivity.
- Coordinated with internal departments to ensure successful execution of projects according to timeline and budget constraints.
- Implemented new technologies, such as LIMS and Excelsafe tools, to streamline lab processes and improve the efficiency.
- Managed annual budgeting process, including forecasting and financial analysis to optimize resources.
- Managed a team of 30+ employees by providing guidance, recruitment, training, setting goals and objectives, delegating tasks, monitoring performance, and robust career path deployment succession plan.
- Implemented quality control cGXP and GLP measures to uphold company standards.
Senior Manager – Analytical Development - R&D
TEVA India Pvt. Ltd.
Mumbai
10.2007 - 12.2018
- Company Overview: TEVA Pharma R&D
- Lead the team in the laboratory comprising of Executives and Officers, in execution of development projects, Pre-approval stability studies, method remediation activities, Support in Pivotal Batches, Laboratory compliance- GLP/GMP/EHS for US, EU and Japan Projects etc.
- Lead the team for Analytical method development.
- Guide the team in method development, method validation, and troubleshooting other undertaken activities.
- Plan and monitor day to day analytical activities of the team.
- Co-ordination in providing the analytical support to Formulation Development and Product /Process validation activities.
- Liaise with Formulation development, Regulatory, Materials management and Other Functional areas to meet project and team Objectives.
- Monitor stability testing of Development batches, Bio / Pilot batches, Pivotal Batches and other stability samples.
- Review of the queries received from PMDA Japan, co-ordination with regulatory team and planning and execution of justification summary or study.
- Review of analytical raw data records, development specification, protocols, reports, specifications, SOPS and other documents.
- Ensure that the laid down GLP and Quality Systems are implemented in the Laboratory.
- Monitor the implementation of calibration & preventive maintenance program for instruments equipment’s in the laboratory.
- Ensure adequate availability of consumables, reagents & chemicals.
- Provide analytical support for the compilation of Dossiers & ANDAs.
- Send samples to approved contract testing labs and co-ordinate with them for the tests which cannot be performed in-house.
- Lay down & overview the training & qualification program of newly recruited analysts.
- Monitor and control cost effectiveness along with Head-Analytical Laboratory.
- Preparation the monthly activity report.
- Provide support in preparing responses to the queries from regulatory bodies.
- Provide support in preparing CAPA for internal and external agency audits.
- Co-ordination with suppliers for timely procurement of reagents, chemicals, columns and other consumables.
- Co-ordination with service agencies for repairs in case of instrument / equipment breakdown.
Senior Research Scientist – Analytical Development
Nicholas Piramal Research Center
Mumbai
02.2005 - 09.2007
- Company Overview: Pharmaceutical R&D
- Development & Validation of analytical method for FP & API as per guidelines of the regulated market like USA.
- Working as a project leader for abbreviated New Drug Applications (ANDA projects).
- Preparation of Standard Test Procedure, Specifications for API, Excipients and FP, Analytical development report, Standard Operating Procedure, Analytical Validation Protocol and Report.
- Analysis of development samples and stability samples of the drug product.
- Preparation of Technical transfer dossier and Method transfer at QC lab, manufacturing sites.
- Design and performed experiments for analytical method troubleshooting.
- Isolation and identification of Unknown impurities in drug product as per ICH guideline.
- Stability studies of drug product- Preparation of stability study protocol & report, Stability sample analysis, preparation of stability study report and interpretation of stability data.
- Preparation of calibration scheduled for analytical instruments.
- Calibration for the analytical instruments, viz., HPLC, UV, dissolution etc and Qualification of new instrument.
- Compatibility study of drug with placebo for various dosages forms.
- Preparation of Monthly summary report for the concerned project.
- Pharmaceutical R&D
Research Officer – Analytical Development
Macleods Pharmaceutical Research Center
Mumbai
01.2004 - 01.2005
- Development & Validation of analytical method for various dosage forms & API for regulated markets.
- Working as a Group leader for validation group, Preparation and checking of Analytical Validation Protocol and Report.
- Planning for validation group and arrangements for validation requirements like HPLC, columns, sample etc.
- Preparations of Technical Transfer Dossier and Analytical Method transfer at site (QC).
- Analytical method troubleshooting and demonstration at different locations.
- Preparation of various document as per regulatory requirement for laboratory set up.
- Checking of analytical raw data for validation group.
- Preparation of monthly report and summary of activity of validation group.
- Preparation of Standard Test Procedure (STP) for different products & Standard Operating Procedure (SOP) for instruments.
Officer- (Analytical Validation)- (ANDA)
SUN Pharmaceutical Ind. Ltd
Halol-Baroda
10.2000 - 01.2004
- Working for abbreviated New Drug Applications (ANDA projects).
- Validation of analytical method for various dosage forms & API for ANDA projects.
- Working on Metered dose inhalers (MDI) and Nasal spray solution product.
- Preparation and checking of Analytical Validation Protocol and Report.
- Innovator comparison study.
- Development and validation of analytical method for cleaning validation.
- Calibration for the various Laboratory instruments and performing IQ OQ and PQ of instrument.
- Preparation of Standard Test Procedure (STP) for different products & Standard Operating Procedure (SOP) for instruments.
- Compatibility study for drug with placebo & degradation study for container closure system.
- Impurity profiling and forced degradation study for various dosage forms.
- Documentation and activity related to technology transfer of product to the site.
- Analysis for assay test methods, related substances, dissolution and preservative content by HPLC, titrimetric & spectrophotometry as per compendial method or as per DMF.
Education
Master of Science - Chemistry
MKU
Madurai, India01-2006
Bachelor of Science - Chemistry
North Maharashatra University
Jalgaon, India01-1998
Skills
- Department leadership
- Analytical Method Development
- Analytical Method Validation
- Analytical Method Transfer
- AS&T and QC Processes
- Laboratory compliance, cGxP, inspection, and audit management
- QMS, RCA, CAPA, Risk assessment
- CMO/CDMO management
- Cross-functional collaboration
- Problem solving and risk management
- Strategic planning and quality management
- Regulatory and quality compliance
- Project timeline management
- Operational efficiency
- Forecasting and planning
- People management & development
References
- Dr. Pravin Phatak, Sr. Director, Pharma R & D, USV Research center, Mumbai, India, (+91-9322193422)
- Mr. Mahesh Fukey, Sr. Director – Analytical Development, LUPIN Pharma R & D center, Pune, India, (+91-8879449526)
Languages
- English
- Marathi
- Hindi
Personal Information
- Date of Birth: 05/25/77
- Nationality: Indian
Affiliations
- Leadership role: Quality culture leader and employee welfare committee
Accomplishments
- Best Employee of the Year Award by the CEO (2024)
Certification
- Certifications for 2 days workshop on Highly Effective Manager skills
Languages
Hindi
First Language
English
Proficient (C2)
C2
Chinese (Mandarin)
Beginner (A1)
A1
References
References available upon request.
Timeline
Senior Manager–Analytical Development/CMC GMP Lab
LOTUS Pharmaceuticals Ltd (ALVOGEN company)
01.2019 - Current
Senior Manager – Analytical Development - R&D
TEVA India Pvt. Ltd.
10.2007 - 12.2018
Senior Research Scientist – Analytical Development
Nicholas Piramal Research Center
02.2005 - 09.2007
Research Officer – Analytical Development
Macleods Pharmaceutical Research Center
01.2004 - 01.2005
Officer- (Analytical Validation)- (ANDA)
SUN Pharmaceutical Ind. Ltd
10.2000 - 01.2004
Master of Science - Chemistry
MKU
Bachelor of Science - Chemistry
North Maharashatra University
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