Sandip Kumar Dey
Kolkata
Summary
Analytical research professional with over 21 years of experience in the pharmaceutical industry. Expertise in designing and executing experiments for drug substances and products, ensuring compliance with cGMP standards, and producing detailed technical reports.
Proven ability to drive team success through strategic thinking and effective communication in highly regulated environments. Committed to leveraging skills to contribute to organizational growth and leadership.
Overview
21
21
years of professional experience
Work History
Group Lead (Lab Head), AVL,
TCG Lifesciences Pvt. Ltd.
Kolkata
03.2017 - Current
- Providing the strategic direction and technical guidance to the analytical department, overseeing a team of 20 scientists including team leads, reporting to Senior VP.
- Spearhead analytical development for the company’s DS (small molecule) portfolio for both in-house and client driven projects across multiple development phases for India, US and Europe.
- Ensure the optimal resource planning and budget allocation, also coordinate with CROs, CMOs/ CDMOs, and CFTs to deliver the projects on time and to quality expectations.
- Oversee the tech transfer from R&D to commercial manufacturing, ensuring robust analytical methods and seamless scale-up.
- Serve as the primary regulatory liaison for analytical audits, managing responses to regulatory authorities, and to client site.
- Successfully led teams through multiple successful regulatory inspections (USFDA, NABL, CDSCO), resulting in zero major observations.
- Direct OOS/ OOE/ OOT investigations, root-cause analyses, and CAPA implementations to maintain cGMP standards.
- Oversee administrative responsibilities including lab governance, recruitment, training and team building initiatives.
Senior Scientist, GDD,
Novartis Healthcare Pvt. Ltd.
Hyderabad
08.2013 - 02.2017
- Managed end-to-end analytical activities including method development, method validation, method transfer, release, and stability testing programs for new chemical entities (NCEs) for early phase and late phase DS (small molecule) & DP (solid orals, liquid orals etc.), overseeing a dedicated team of 4-5 scientists.
- Supported Regulatory & CMC activities, providing analytical data and documentation for IND, NDA, MAA and global regulatory submission, ensuring compliance with ICH, FDA and EMA requirements.
- Renowned for QbD based analytical method development and validation in accordance to the ICH guidelines.
Assistant Manager, ADL,
Tevapharm India Pvt. Ltd.
Goa
06.2012 - 07.2013
- Managed analytical activities including method development, method validation and method transfer for APIs and generic formulations (solid orals, liquid orals, topicals etc.), overseeing a dedicated team of 10 scientists.
- Provided planning and guidance for the development and validation of analytical methods (IR, UV-Vis, HPLC, UPLC, GC, IC, PSD, LC-MS/MS, and Dissolution) for drug substances and drug products.
- Conducted forced degradation studies and impurity profiling to support development and regulatory filings.
- Conducted in-vitro dissolution profiling, comparison and clearing of test products profiles with Innovator formulations (RLD) for BE studies with proficient understanding in IVIVC.
Executive, ADL,
Sun pharmaceutical Industries Limited
Mumbai
09.2010 - 06.2012
- Conducted analytical activities including method development, method validation and method transfer for generic formulations (solid orals, liquid orals, pellets, etc.),
- Executed the development and validation of analytical methods (IR, UV-Vis, HPLC, UPLC, GC, IC, PSD, and Dissolution) for drug products.
- Conducted forced degradation studies and impurity profiling to support development and regulatory filings.
- In-vitro dissolution profiling, comparison and clearing of test products profiles with Innovator formulations (RLD) for BE studies with proficient understanding in IVIVC.
- De-formulation studies.
- Pre-formulation studies.
- Preparation and implementation of departmental Standard operating procedures (SOP's).
- Supported release, and stability testing programs.
Assistant Manager, ADL,
Dr. Reddy laboratories Ltd
Hyderabad
04.2007 - 09.2010
- Conducted analytical activities including method development, method validation and method transfer for generic formulations (solid orals, liquid orals, pellets, etc.),
- Executed the development and validation of analytical methods (IR, UV-Vis, HPLC, UPLC, GC, and Dissolution) for drug products.
- Conducted forced degradation studies and impurity profiling to support development and regulatory filings.
- Supported in-vitro dissolution profiling, comparison and clearing of test products profiles with Innovator formulations (RLD) for BE studies with proficient understanding in IVIVC.
- De-formulation studies.
- Pre-formulation studies.
- Conducted release, and stability testing programs.
Officer, ADL,
Glenmark Lab. Ltd.
Goa
05.2006 - 04.2007
- Conducted analytical activities including method development, method validation and method transfer for generic formulations (solid orals, liquid orals, etc.),
- Executed the development and validation of analytical methods (IR, UV-Vis, HPLC, UPLC, GC, and Dissolution) for drug products.
- Conducted forced degradation studies and impurity profiling to support development and regulatory filings.
- Supportrd in-vitro dissolution profiling, comparison and clearing of test products profiles with Innovator formulations (RLD) for BE studies with proficient understanding in IVIVC.
- Pre-formulation studies.
- Conducted release, and stability testing programs.
Executive, Quality Control,
National Health Care Pvt. Ltd.
Bara, Nepal
04.2005 - 04.2006
- Conducted analytical activities including method development, method validation and method transfer for APIs and branded formulations (solid orals, liquid orals, topicals, etc.),
- Executed the development and validation of analytical methods (UV-Vis, HPLC, and Dissolution) for drug substances and drug products.
- Conducted release, and stability testing programs.
Education
Master of Pharmacy - Pharmaceutical chemistry
College of Pharmaceutical Sciences
Brahmapur, OR01-2005
Bachelor of Pharmacy - Pharmacy
Institute of Pharmacy & Technology
Cuttack, OR01-2002
PhD - Pharmaceutical chemistry
GITAM University
Visakhapatnam, APFunctional Skill
- New Product Development
- Method Development
- Method Validation
- Method Transfer
- Routine, Release & Stability
- Workflow Management
- Qualification & CSV
- Calibration & Preventive Maintenance
- Audit & Compliance
- Investigation Management
- Safety
Managerial Skill
- Strategic Leadership: AR&D Operations, CAPEX & OPEX, Resource Allocation
- Analytical Operations: Method Development, Validation, Forced Degradation, Impurity Profiling
- Regulatory & Quality: USFDA, EMA, CDSCO, and ICH Guidelines Compliance
- Project Management: Cross-Functional Collaboration, Technology Transfer
- Risk Management: Investigations Management, CAPA
Analytical Skill
- Creativity: Excellent
- Problem Solving: Excellent
- Data Analysis: Excellent
- Critical Thinking: Excellent
- Research: Excellent
Languages
Bengali
Proficient
C2
Hindi
Proficient
C2
English
Proficient
C2
Computer Proficiency
- Microsoft Word
- Microsoft Excel
- Microsoft Power Point
- Chemdraw
- LIMS
- Trackwise
- Design Expert
- SAP
Personal Information
- Father's Name: Subodh Kumar Dey
- Date of birth: 04-March-1980
- Nationality: Indian
- Marital status: Married
- Passport details: P5888954
Address
Flat No-5C, Block B, Unique Woods,
Mondal para, Solua, Rajarhat Gopalpur,
Kolkata, West Bengal, 700136
Area Of Expertise
- Team leadership
- Laboratory operations
- Data collection and accurate record keeping (ALCOA++)
- Policies, procedures and regulatory compliances
- Regulatory audits
- Project delivery
- Study management
- Creative problem solver
- Process analysis
- Client relations
- Staff motivation
References
- Mr. Raghavendra Prabhu, Site head, Baxter India Pvt. Ltd., Bengaluru, +91 96420 32666
- Mr. B. Sriman Narayana, API-AGM, AR&D, R&D Center, MSN Labs., Hyderabad, +91 99630 02828
Disclaimer
I, hereby declare that the above information is true to the best of my knowledge and belief.
Timeline
Group Lead (Lab Head), AVL,
TCG Lifesciences Pvt. Ltd.
03.2017 - Current
Senior Scientist, GDD,
Novartis Healthcare Pvt. Ltd.
08.2013 - 02.2017
Assistant Manager, ADL,
Tevapharm India Pvt. Ltd.
06.2012 - 07.2013
Executive, ADL,
Sun pharmaceutical Industries Limited
09.2010 - 06.2012
Assistant Manager, ADL,
Dr. Reddy laboratories Ltd
04.2007 - 09.2010
Officer, ADL,
Glenmark Lab. Ltd.
05.2006 - 04.2007
Executive, Quality Control,
National Health Care Pvt. Ltd.
04.2005 - 04.2006
Master of Pharmacy - Pharmaceutical chemistry
College of Pharmaceutical Sciences
Bachelor of Pharmacy - Pharmacy
Institute of Pharmacy & Technology
PhD - Pharmaceutical chemistry
GITAM University