RABIN SURCHAUDHARY
DGM- Production
Kalyani
Summary
An accomplished professional having 26 years of diverse experience in the pharmaceutical industry. Excel in multifaceted roles encompassing Manufacturing, Formulation services, On-site and offsite operations, Quality management systems (QMS), Supply Chain functions, Regulatory Affairs, and Corporate Leadership.
Rich experience in refining operational workflows for heightened efficiency, ensuring regulatory compliance, fostering a culture of innovation, and driving the implementation of strategic endeavors pivotal for organizational progress.
Overview
27
27
years of professional experience
2
2
Certifications
Work History
DGM - Production
Fresenius Kabi Oncology Ltd
11.2019 - Current
- Strategizing planning and overseeing API manufacturing operations at the site.
- In charge of Plant Modernization, New Product Introductions, Digitalization, Automation, Quality Culture Enhancement, Cost Savings, and ESG Initiatives.
- Budgeting, Resource Planning, Cost Optimization, Regulatory Audits (e.g., EDQM, MHRA, COPEFRIS, TGA), and Compliance Governance.
Associate Director - Mfg. Services
Mylan laboratories Ltd
02.2017 - 11.2019
- Commissioning and commercializing complex injectable formulations for regulated markets.
- Cross collaboration & Tech transfer of complex processes and novel drug delivery technologies (Microspheres, Nano tech, TFF, Robotic fill, Liposomes, Emulsions, Homogenization, Lyophilization). New product readiness for regulatory inspections (e.g., USFDA, WHO).
Senior manager - Procurement & Contract Mfg-API
Sun Pharma
03.2015 - 02.2017
- Conducting a comprehensive scouting initiative for cost-competitive technologies and products on a global scale, including APIs, advanced intermediates, and biosimilars.
- New regulatory portfolio in corporate procurement team for faster DMF submissions and adept handling of regulatory inquiries.
- Developing a site selection roadmap and formalizing contract guidelines for outsourcing, contract manufacturing, and product commercialization
Contract Manufacturing Division
Ranbaxy
03.2011 - 03.2015
- Overseeing contract manufacturing operations, coordinating technical changes, trials, validations, and product deliveries by collaborating with R&D, manufacturers, regulatory, supply chain, and QA.
- Enhanced operational excellence through reinforcing Quality Management System (QMS) activities, including regulatory audits of Contract Manufacturing Organizations (CMOs).
Production Fermentation Division
Ranbaxy
06.2007 - 02.2011
- Overseeing production, planning, and inventory control in fermentation plant for regulated markets, including regulatory inspections. Commissioning automated manufacturing plant in DCS environment
- Budgeting, operational planning, control, and cost optimization.
Asst Manager - MFG
Wockhardt Ltd
10.2004 - 06.2007
- Overseeing sterile manufacturing techniques and operations for biotech products.
- Developing Vaccines & Biosimilars Team for Erythropoietin API manufacturing process and technology (fermentation and downstream operations)."
- Acquired technical expertise in downstream processing of Insulin and Glargine.
Asst Manager - MFG
RPG life sciences
09.1999 - 10.2004
- Managed project and commissioning of Oncology facility.
- Daunorubicin fermentation and downstream technology. from Pilot to Main plant.
- Enhanced the yield and efficiency of diverse biotech products.
Senior Officer - Production
Rallis India Ltd
09.1997 - 03.1999
- Optimized Dextran fermentation process and downstream technologies.
- Enhanced yield and efficiency of diverse biotech products.
Education
Executive Development Program (Strategy and innovation) -
XLRI
Jamshedpur, Jharkhand 01.2023 - 1 2024
M Tech-Biotech - undefined
Jadavpur University
Kolkata, West Bengal 01.1994 - 1 1996
MSc-Biotech - undefined
GND University
Amritsar, Punjab 01.1992 - 1 1994
BSc-chemistry (HONS) - undefined
University of Delhi (DU)
01.1989 - 1 1992
Skills
CAPSTONE research project On “Removing Humar Barries to foster Innovation “as part XLRI EDP certification
Post graduate diploma in Biotech Business Management from BII Noida
ISO 9000, 5S & Leadership workshop in RPG life sciences
Course in Basic finance and Outbound Training Program on leadership at Ranbaxy Labs
Regulatory guidelines and IPR Topics
Industrial biotech trainee in SIV industries at Biotech R&D division - six months sponsored by Biotech Consortium India ltd, CGO complex New Delhi
GATE 94 cleared
Research and thesis work done as part of MTech and MSc Biotech programs
Niche capabilities: - APIs, Complex injectable, Biosimilars, Vaccines, Fermentations and Downstream Unit operations, Mammalian Cell culture techniques & Novel Drug Delivery systems
Automation & Technology Transfer - Commissioning and commercialization of Green fields projects Designing Media fills strategies and sterile formulations in semi-automated and fully automated systems, Technology absorption , transfer , scale up and validation from lab to Plant along with designing strategies for Cleaning Validation and automation of systems and procedures
Global manufacturing contracts for CMOs, Production planning and Inventory Control, Procurement of advance intermediates and APIs
Regulatory filings, Technical and Contracts due diligence audits and inspections & compliance activities as part of QMS, USFDA and WHO Compliance Readiness
Accomplishments
- Industrial biotech trainee in SIV industries at Biotech R&D division - 6 months sponsored by Biotech Consortium India ltd, CGO complex New Delhi.
- Research and thesis work done as part of MTech and MSc Biotech programs.
- GATE 94 cleared.
- Equipped with Regulatory guidelines and IPR Topics.
- Nominated and completed the Finance and Outbound Training Program for leadership at Ranbaxy Labs.
- Post graduate diploma in Biotech Business Management from BII Noida.
Certification
Advanced Strategic Management & Innovation
Timeline
Advanced Strategic Management & Innovation
01-2024
Executive Development Program (Strategy and innovation) -
XLRI
01.2023 - 1 2024
DGM - Production
Fresenius Kabi Oncology Ltd
11.2019 - Current
Associate Director - Mfg. Services
Mylan laboratories Ltd
02.2017 - 11.2019
Senior manager - Procurement & Contract Mfg-API
Sun Pharma
03.2015 - 02.2017
Contract Manufacturing Division
Ranbaxy
03.2011 - 03.2015
Production Fermentation Division
Ranbaxy
06.2007 - 02.2011
Asst Manager - MFG
Wockhardt Ltd
10.2004 - 06.2007
Asst Manager - MFG
RPG life sciences
09.1999 - 10.2004
Senior Officer - Production
Rallis India Ltd
09.1997 - 03.1999
M Tech-Biotech - undefined
Jadavpur University
01.1994 - 1 1996
MSc-Biotech - undefined
GND University
01.1992 - 1 1994
BSc-chemistry (HONS) - undefined
University of Delhi (DU)
01.1989 - 1 1992