AMOL SAGULALE
Hyderabad
Summary
Dynamic and analytical development professional with over 15 years of specialized experience in method development and validation for injectable formulations, including microspheres, nanosuspensions, iron products, liposomes, and inhalation products. Proven track record of leading cross-functional teams to ensure regulatory compliance and facilitate seamless technology transfers, consistently driving projects to successful outcomes. Expertise in pharmacopoeial method verification combined with a strong ability to develop, review, and maintain specifications for raw materials and drug products in strict alignment with regulatory standards. Recognized for exceptional leadership qualities and effective communication skills, fostering collaboration across departments to meet and exceed organizational objectives while serving as an Expert Panel Member for the development of General Chapter Polymer Microparticle Drug Products – Characterization Methods in the U.S. Pharmacopeial Convention.
Overview
16
16
years of professional experience
Work History
Team Leader- Analytical Development (Complex Injectable Formulation)
Viatris (A Mylan Company)
02.2020 - Current
- Spearheaded analytical method development and validation for complex injectable formulations, including Microsphere and nano-suspensions and iron products.
- Optimized dissolution methods for injectable Microspheres and suspensions, improving drug release profiles and achieving reduction in analysis time.
- Conducted reverse engineering of diluents in depot injectable suspensions, estimating excipient concentrations to ensure product quality.
- Led method development and validation for particle size analysis using Laser Diffraction Technique , optimizing parameters for product stability studies; validated particle size methods.
- Mentored four junior analysts in analytical method development and validation techniques, ensuring adherence to regulatory guidelines.
- Streamlined analytical testing processes by implementing automation and data analysis tools, reducing turnaround time and improving data quality.
- Managed analytical projects, ensuring on-time completion,adherence to project timelines, coordinating with cross-functional teams.
- Established open and professional relationships with team members to achieve quick resolutions for various issues.
- Managed conflict resolution among team members, fostering a positive and collaborative work environment.
- Provided ongoing support to direct reports, addressing concerns or questions promptly so they could remain focused on their tasks.
Research Officer - Analytical Development (Complex Injectable Formulation R&D)
Glenmark Pharmaceuticals
04.2016 - 02.2020
- Managed 4+ analytical R&D projects for drug substance and product development of complex injectable suspensions, leading cross-functional teams.
- Developed and validated analytical methods for assay, dissolution, and related substances testing of complex injectables.
- Characterized particle size distribution using Next Generation Impactor (NGI), Zetasizer, and Malvern Mastersizer 3000.
- Verified USP analytical methods, ensuring compliance with pharmacopeial standards through rigorous documentation and reporting.
- Optimized analytical methods, achieving a 15% reduction in analysis time while improving accuracy and precision of assay methods.
- Maintained accurate records of experimental data, ensuring integrity and accessibility for future analyses.
- Conducted literature reviews to inform research design and ensure relevance to current industry trends.
Research Assistant-I (Complex Injectable Formulation R&D)
Sun Pharma Advance Research Company (SPARC)
04.2014 - 04.2016
- Developed and validated analytical methods for assay, IVR, and related substances in liposomal and depot formulations, adhering to ICH guidelines.
- Conducted particle size and zeta potential analysis using Malvern Mastersizer 3000 and Zetasizer, analyzing samples for NDDS formulations.
- Quantified assay, free drug, entrapment, IVR, and related substances in in-process, finished product, and stability samples per batch.
- Troubleshooted HPLC issues, identifying and resolving problems during routine analysis, reducing downtime and ensuring data integrity.
- Coordinated with senior scientists to complete analytical research and development projects within established timelines.
- Participated actively in regular meetings with fellow researchers to discuss project updates, challenges faced, and lessons learned during ongoing activities.
- Managed laboratory equipment and resources, ensuring proper maintenance and optimal functionality.
- Conducted literature reviews to support hypothesis development and identify gaps in existing knowledge.
- Maintained open lines of communication with project leads and team members for effective collaboration on common goals.
Senior Research Associate-II, Analytical R&D-Solid Oral
Macleods Pharmaceuticals
01.2013 - 03.2014
- Conducted analytical testing using in-house and USP methods for raw materials, in-process, and finished products
Performed preformulation studies analyzing compatibility of excipients with APIs, evaluating 20 excipient combinations to optimize formulations.
Managed stability studies, maintained records, and monitored samples, adhering to ICH guidelines and generating data for product shelf-life determination across 10 studies. - Mentored junior researchers, contributing to their professional growth and development.
- Initiated, planned and executed research projects under supervision of senior scientist.
- Achieved project objectives by troubleshooting experiments and testing practical and creative solutions.
Research Scientist-I, Analytical R&D-Herbal Formulation
Tulip Lab Pvt. Ltd.
05.2010 - 10.2012
- Developed and validated analytical methods using HPLC, HPTLC, and UV spectrophotometry for plant extracts and herbal formulations.
- Optimized HPTLC mobile phases, achieving improvement in resolution of plant extract components for accurate fingerprinting profiles.
- Streamlined extraction protocols, optimizing experimental conditions for herb extraction and increasing yield of bioactive compounds.
- Conducted preformulation studies, testing excipients for compatibility with plant extracts to prevent formulation issues.
- Resolved analytical issues during routine analysis, ensuring data integrity and accuracy of results.
- Enhanced methodology and technology through continuous improvement initiatives, saving hours/week and reducing costs.
- Performed research into study topics to increase knowledge and to provide valuable contributions.
- Provided qualified input and development support for development plans and study protocols.
- Conducted comprehensive literature reviews to inform research directions, ensuring projects were aligned with latest scientific developments.
- Facilitated knowledge exchange by organizing regular scientific seminars, promoting culture of continuous learning within research team.
Education
M. Pharm. - Pharmacognosy
RTMNU, Nagpur University
Nagpur01.2010
Post Graduate Diploma - Regulatory Affairs
Global Institute of Regulatory Affairs
Pune01.2010
B. Pharm. - undefined
SGBA Amravati University
Amravati01.2007
Skills
- Analytical development skills
- Complex Injectable Formulation
- Technical documentation expertise
- Timely query resolution
- SOP documentation expertise
- Product research and innovation
- Validation and transfer management
- Knowledge of regulatory standards
- Data-driven decision making
- Team alignment across functions
- Team leadership
- Effective presentation skills
- Attentive listener
Languages
English
Hindi
Marathi
References
- Surendra, Singh Rao, Director, Complex Injectable, R&D, +91-9920125539, 969225020, Par Pharma, Navi Mumbai, Maharashtra
- Murlidhar, Zope, Associate VP- Complex Injectable,R&D, +91-9426721880, Sun Pharma, Vadodara, Gujrat
Timeline
Team Leader- Analytical Development (Complex Injectable Formulation)
Viatris (A Mylan Company)
02.2020 - Current
Research Officer - Analytical Development (Complex Injectable Formulation R&D)
Glenmark Pharmaceuticals
04.2016 - 02.2020
Research Assistant-I (Complex Injectable Formulation R&D)
Sun Pharma Advance Research Company (SPARC)
04.2014 - 04.2016
Senior Research Associate-II, Analytical R&D-Solid Oral
Macleods Pharmaceuticals
01.2013 - 03.2014
Research Scientist-I, Analytical R&D-Herbal Formulation
Tulip Lab Pvt. Ltd.
05.2010 - 10.2012
Post Graduate Diploma - Regulatory Affairs
Global Institute of Regulatory Affairs
B. Pharm. - undefined
SGBA Amravati University
M. Pharm. - Pharmacognosy
RTMNU, Nagpur University