Mandar Krishna Manolikar
Bangalore
Summary
An accomplished analytical scientist with over 22 years of success in pharmaceutical R&D, specializing in analytical method development, validation, and lifecycle management for Drug products. Proven expertise in applying Quality by Design (QbD) and regulatory frameworks (ICH, USP, FDA) to develop robust methods and clinically relevant specifications. A strategic leader with a passion for mentoring scientific teams, managing cross-functional projects, and driving innovation in global development and manufacturing environments. Committed to advancing public health through science-driven standards and collaborative excellence.
Overview
22
22
years of professional experience
Work History
Senior Team Leader
Syngene International Limited
06.2016 - Current
- Led and managed a diverse team of over 20 analytical scientists, delivering top-notch analytical procedures for 30+ projects, including Animal Health (New Drug Products), NCEs (FIH clinical studies formulation development, CMC development), and Generics (505 B2 type applications), contributing to 8+ successful regulatory filings.
- Successfully developed, validated, and transferred analytical methods for complex drug products to 6+ global sites for 8+ projects.
- Developed dissolution methods for complex oral dosage forms using QbD principles, ensuring robust discriminatory capacity and clinically relevant specification setting per USP/ and ICH Q6A, supporting successful regulatory submissions.
- Maintained high-touch coordination with international clients and CROs, achieving an NPS score of 8+ and ensuring timely execution of global development milestones.
- Implemented project requirement-specific (FFS & FTE) planning strategies, achieving >95% on-time delivery, reducing the analysis turnaround time by 20%.
- Enhanced team agility and performance through proactive cross-training, fostering efficient and productive operations.
- Conceptualized Analytical Data workflow automation with Agentic AI and led the implementation of automated workflows; Instrumental in Laboratory Digitalization implementations.
- Prioritized and emphasized safety to establish a secure environment for team members and patrons.
Assistant Manager, Pharma Polymers
Evonik India Pvt. Ltd.
09.2010 - 05.2016
- Spearheaded analytical characterization initiatives focused on advancing the characterization of the Eudragit polymer range and optimizing their application technologies, directly supporting product innovation.
- Contributed significantly to 3 technology patents and generated 2 project ideas, leading to the successful implementation of 2 new analytical technologies that enhanced research capabilities.
- Managed up to 5 complex projects simultaneously, consistently achieving >95% on-time milestone delivery within aggressive timelines.
- Developed and implemented comprehensive safety policies and procedures, ensuring full compliance with regulations and fostering a secure work environment.
Senior Research Associate
International Pharma-science Center, Ferring Pharmaceuticals
10.2008 - 06.2010
- Developed molecular weight determination methods for novel excipients; supported characterization and specification setting for novel excipients.
- Aided formulation teams in lyophilization cycle optimization using DSC and Hot Stage Microscopy.
- Implemented taste assessments using an electronic tongue instrument (Insent Taste Sensing system).
Associate Research Scientist
Pharmaceutical Technology Centre, Cadila Healthcare Ltd
01.2007 - 09.2008
- Spearheaded the RLD (Reference Listed Drug) reverse engineering efforts for the team; Developed >6 chromatographic methods and coordinated with >4 external laboratories for precise quantification of excipients in RLD solid oral dosage formulations.
- Developed robust stability-indicating chromatographic methods for multiple ANDA projects, covering both single-component and fixed-dose combination products.
- Managed and executed analytical activities for the assigned ANDA projects, monitored stability trends for developmental products in collaboration with formulation scientists, identifying critical factors influencing product shelf-life.
Research Associate
Aurobindo Pharma Ltd. – Research Centre (Unit- II)
10.2004 - 01.2007
- Developed and validated stability-indicating analytical methods for 4+ ANDA projects, ensuring robust and reliable product analysis.
- Facilitated the successful transfer of multiple analytical methods from Analytical Development to the Quality Control (QC) department, ensuring seamless transition and operational readiness.
- Created, verified, and implemented 10+ calculation spreadsheets to standardize and enhance the accuracy of analytical results for both routine tests and method validation experiments.
- Actively contributed to the generation of critical project documentation, including method development reports, STPs (Standard Test Procedures), and specifications, while also preparing SOPs (Standard Operating Procedures) for instruments and equipment.
Analytical Chemist
Pharmasolve Specialities India Pvt Ltd. (Subsidiary of Cipla India Ltd.)
02.2003 - 09.2004
- Developed expertise in qualitative impurity isolation for Active Pharmaceutical Ingredients (APIs), successfully scaling up methods from analytical to semi-preparative HPLC for effective impurity separation.
- Conducted comprehensive analysis of multiple finished products (including tablets, capsules, and solutions) and raw materials (API, excipients, and enzymes) by following the in-house and pharmacopeial (e.g., USP/BP/IP) specifications, utilizing a range of wet chemical and chromatographic methods.
- Contributed as a certified member of the Site Emergency Response Team, actively participating in safety drills and incident response.
Education
Senior Management Program (SMP) -
Indian Institute of Management (IIMV)
Vishakhapatnam09.2025
Advanced Data Analytics for Managers: Data Analytics -
Indian Institute of Management (IIMK)
Kozhikode05.2023
Master of Science - Chemistry - By Research
University Institute of Science And Technology (Current Name – ICT), Univ. Of Mumbai
MMumbai, India02.2003
Bachelor of Science - Chemistry
K.V.Pendharkar College, Univ. Of Mumbai
Thane, India06.1999
Higher Secondary School Certificate - Science
K.V.Pendharkar College, Maharashtra State Board
Dombivli, Thane, India 05.1996
Secondary School Certificate - General Studies
Tilak Nagar High School, Maharashtra State Board
Dombivli, Thane, India05.1994
Skills
- Development and validation of analytical methods
- Quality by design expertise
- Regulatory compliance
- Leadership and mentoring
- Strategic planning & Project Management
- Client and stakeholder collaboration
- Data analytics expertise
- Effective communication
- Effective problem resolution
- Training and mentoring
- EHSS compliance and implementation
Disclaimer
Date: Place: Signature
Timeline
Senior Team Leader
Syngene International Limited
06.2016 - Current
Assistant Manager, Pharma Polymers
Evonik India Pvt. Ltd.
09.2010 - 05.2016
Senior Research Associate
International Pharma-science Center, Ferring Pharmaceuticals
10.2008 - 06.2010
Associate Research Scientist
Pharmaceutical Technology Centre, Cadila Healthcare Ltd
01.2007 - 09.2008
Research Associate
Aurobindo Pharma Ltd. – Research Centre (Unit- II)
10.2004 - 01.2007
Analytical Chemist
Pharmasolve Specialities India Pvt Ltd. (Subsidiary of Cipla India Ltd.)
02.2003 - 09.2004
Senior Management Program (SMP) -
Indian Institute of Management (IIMV)
Advanced Data Analytics for Managers: Data Analytics -
Indian Institute of Management (IIMK)
Master of Science - Chemistry - By Research
University Institute of Science And Technology (Current Name – ICT), Univ. Of Mumbai
Bachelor of Science - Chemistry
K.V.Pendharkar College, Univ. Of Mumbai
Higher Secondary School Certificate - Science
K.V.Pendharkar College, Maharashtra State Board
Secondary School Certificate - General Studies
Tilak Nagar High School, Maharashtra State Board
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