SUNIL ANKULGE
Thane
Summary
Strategic leader in pharmaceutical operations with over 21 years of experience in OSD and sterile manufacturing. Expertise in technology transfer, commercialization, and regulatory compliance, successfully executing over 100 product transfers in US FDA and global markets. Recognized for enhancing plant performance through risk-based decision-making and continuous improvement initiatives. Proven ability to build high-performance teams and align manufacturing strategies with business growth objectives.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Sr. Director
PAR Health
Chennai / Mumbai
12.2019 - Current
- Heading the Tech services team of Chennai and Mumbai within Technical Operations for OSD Manufacturing, my key responsibilities include New Product, site transfers and new product launches: managing the seamless transfer of products between R&D, sites and overseeing successful new product introductions.
- Commercial Product Support: Providing technical oversight for ongoing commercial production to maintain quality, efficiency, and regulatory compliance.
- Continuous Improvement: Driving process and product improvements through innovation, technology adoption, and operational excellence initiatives.
- Ensured compliance with regulatory guidelines by implementing strategies to identify and mitigate nitrosamine risks.
- Established agile working environment, enabling rapid response to changing business needs while maintaining quality and performance standards.
- Conducted continuous evaluations of business facilities, teams, and policies to enhance operational efficiency and consistency.
- Developed strong relationships with key industry partners, fostering collaboration and mutual growth opportunities.
- Supported sterile team in executing clinical trials and evaluating study results.
Assistant General Manager
Amneal Pharmaceutical ltd.
Ahmedabad
10.2016 - 12.2019
- Lead Technology Transfer Initiatives: Managed the entire spectrum of technology transfer, from laboratory scale to pilot scale (Exhibit) and further to commercial scale, with a focus on ANDA filing products.
- New Product transfer and filling: Every year more than 20 product Submission batches executed and filled to regulatory agency. Most of the product without any query on process.
- Coordinated overseas site transfers to India, managed dossier reviews and feasibility lab trials, and executed submission batches.
- Identified and resolved process-related issues while optimizing process parameters, leading to quality improvements in commercial batches.
- Enhanced communication among team members through regular meetings, promoting an open dialogue about challenges and opportunities for improvement.
- Developed and implemented operational procedures to streamline daily tasks and enhance overall efficiency.
Manager
Mylan laboratories Ltd.
Indore
04.2014 - 10.2016
- Managed and motivated employees to be productive and engaged in work.
- Executed more than 25 products every year for various regulatory agency filling to achieve the organizational goals.
- Launched new product on time by conducting product risk assessment and executing pre-validation batches.
- Oversaw transfer of solid oral and potent drug products, ensuring compliance with safety and quality standards.
- Reviewed technical documents to optimize processes that maintained product life cycle.
- Facilitated team brainstorming sessions that generated innovative solutions to address operational challenges.
Senior Research Scientist
Famy care Ltd
Ahmedabad
09.2008 - 04.2014
- Managed technology transfer activities for solid oral and sterile products across all sites, overseeing validation and lifecycle management of potent drug products.
- Successfully transferred the sterile emulsion injection product, which is currently the only generic available on the market.
- Executed regulatory filings for 72 products to various regulatory agencies, ensuring compliance and facilitating market access.
- Promoted to Lead Technology Transfer team within three and a half years of joining as Senior Officer.
Production Officer
Alkem Laboratories Ltd.
Daman
09.2007 - 08.2008
- Production Officer - Sterile Department (Dry Powder and Liquid Injections) Worked as production officer in Sterile dept (Dry powder and Liquid Inj.).
- Oversaw daily production activities across parenteral manufacturing lines, ensuring compliance with safety and quality standards.
- Supervised sterile manufacturing operations from vial washing to final packing, maintaining operational integrity and product quality.
- Created standard operating procedures for production processes, enhancing output quality consistency across shifts.
- Hands-on experience in handling Dry Powder Injection and Liquid Injection areas, including execution and oversight of Media Fills.
Senior Technical Assistant
Torrent Pharmaceutical
Ahmedabad
04.2006 - 08.2007
- Oversaw shop floor activities, ensuring accurate filling of batch manufacturing records (BMR) to maintain compliance during production.
- Managed granulation and compression area during shifts, coordinating efforts to meet production targets.
- Managed technical documentation for compliance and regulatory submissions.
- Coordinated cross-functional meetings to streamline project workflows and communication.
- Assisted in developing training materials for new team members and processes.
Management Staff
CIPLA Ltd.
Verna Goa
06.2004 - 04.2006
- Initiated professional journey in production department, gaining foundational experience in pharmaceutical industry.
- Specialized in granulation department, enhancing skills to support manufacturing and quality control processes.
- Coordinated cross-functional teams to enhance project workflows and communication.
- Developed training programs for new staff to ensure compliance with company standards.
- Managed inventory processes, ensuring timely replenishment and accurate tracking.
Education
Master of Pharmacy - Pharmaceutical Sciences
Manosarovar Global University
BhopalBachelor of Pharmacy -
SVPM's Collage of Pharmacy
Malegaon, Baramatiundefined
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Skills
- Strategic planning
- Project management
- Operations management
- Process optimization
- Operational excellence
- Technology transfer
- Cross-functional leadership
- Stakeholder relations
- Collaborative leadership
- Continuous improvement
- Problem solving
Websites
Certification
- Six Sigma Green Belt
- Operations Management and Analytics (PGCP) IIM - pursuing
Personal Information
Title: SR. DIRECTOR TECHNICAL OPERATION
Recognition
Employee Recognition Scheme, Famy Care Ltd, honored with the prestigious 'Employee Recognition Scheme' Award by Famy Care for exceptional individual contributions in successfully managing product transfer initiatives.
Timeline
Sr. Director
PAR Health
12.2019 - Current
Assistant General Manager
Amneal Pharmaceutical ltd.
10.2016 - 12.2019
Manager
Mylan laboratories Ltd.
04.2014 - 10.2016
Senior Research Scientist
Famy care Ltd
09.2008 - 04.2014
Production Officer
Alkem Laboratories Ltd.
09.2007 - 08.2008
Senior Technical Assistant
Torrent Pharmaceutical
04.2006 - 08.2007
Management Staff
CIPLA Ltd.
06.2004 - 04.2006
Master of Pharmacy - Pharmaceutical Sciences
Manosarovar Global University
Bachelor of Pharmacy -
SVPM's Collage of Pharmacy