Summary
Overview
Work History
Education
Skills
Websites
Certification
Accomplishments
Skills - Niche Capabilities
Timeline
Generic

Rabin Kumar Surchaudhary

Pharmaceutical Business
Kalyani

Summary

Accomplished professional with diverse experience in the pharmaceutical industry. Excels in multifaceted roles spanning manufacturing, formulation services, on-site and offsite operations (contract manufacturing operations), green field projects commissioning, project management, quality management systems (QMS), supply chain functions, procurement, regulatory affairs, and corporate leadership. Rich background in refining operational workflows for heightened efficiency through effective people management and ensuring regulatory compliance. Committed to fostering a culture of innovation and driving the implementation of strategic endeavors that are pivotal for organizational progress.

Overview

28
28
years of professional experience
10
10
years of post-secondary education
2
2
Certifications
3
3
Languages

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, Expansion and commissioning of new facilities.
  • 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.
  • Fostering and development of the Innovation culture on site by introduction of various cost improvement measure, Continuous improvement of processes; and various initiatives towards improving the operational efficiencies.

Associate Director - Mfg. Services

Mylan laboratories Ltd
02.2017 - 11.2019
  • Commissioning and commercializing complex injectable formulations for regulated markets.
  • Commissioning of Robotic filing Machine & Lyophilization.
  • Cross collaboration & Tech transfer of complex processes and novel drug delivery technologies (Microspheres, Nano tech, TFF, Robotic fill, Liposomes, Emulsions, Homogenization, Lyophilization, Sterile Powder fill).
  • 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.
  • Entire Supply chain management of outsourcing products.
  • 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
  • Entire Supply chain Management of Outsourced Product Business.
  • Identification and development of Contract manufacturing sites.
  • 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 (Statins) for regulated markets, including regulatory inspections.
  • Commissioning automated manufacturing plant in DCS environment.
  • Budgeting, operational planning, control, and cost optimization.

Asst Manager - Production

Wockhardt Ltd
10.2004 - 06.2007
  • Overseeing sterile manufacturing techniques and operations for biotech products.
  • Developing Vaccines (Hep-B) & 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 - Production

RPG life sciences
09.1999 - 10.2004
  • Commissioning of Oncology facility and technology transfer of products.
  • Commercialized the Daunorubicin & Cyclosporin fermentation and downstream technology from Pilot to Main plant.
  • Enhanced the yield and efficiency of diverse biotech products.

Senior Officer - Production

Rallis India Ltd
03.1997 - 09.1999
  • Involved in commissioning and Commercialization of fermentation & formulations facility.
  • Optimized Dextran fermentation process and downstream technologies.
  • Enhanced yield and efficiency of diverse biotech products.

Education

Executive Program in Senior Management - Pursuing

Indian Institute of Management (IIM)
Visakhapatnam, Andhra Pradesh
06.2024 - 06.2025

Executive Development Program - Strategy and innovation

XLRI
Jamshedpur, Jharkhand
04.2023 - 01.2024

Post Graduate Diploma in Biotech Business Management - undefined

Bioinformatics’ Institute of India
Noida, Uttar Pradesh
06.2005 - 01.2007

M Tech - Biotechnology

Jadavpur University
Kolkata, West Bengal
11.1994 - 06.1996

MSc - Biotechnology

GND University
Amritsar, Punjab
09.1992 - 09.1994

BSc - Chemistry (Honours)

University of Delhi (DU)
07.1989 - 08.1992

Skills

  • Pharmaceutical operations management

  • Knowledge of active pharmaceutical ingredients

  • Advanced injectable formulations

  • Biosimilars development experience

  • Vaccines

  • Proficient in fermentation processes

  • Process optimization in downstream unit operations

  • Advanced mammalian cell culture techniques

  • Innovative drug delivery systems

  • Project oversight

  • Project execution oversight

  • Product commercialization

  • Process automation

  • Experience in facilitating technology transfer

  • Technology integration

  • Increase operational capacity

  • Process validation

  • Cleaning validation processes

  • Skilled in injectable procedures

  • Developing media fill strategies

  • Aseptic formulations

  • Efficiency improvement

  • Incremental improvement strategies

  • Budget management

  • Third-party manufacturing oversight

  • Strategic production planning

  • Supply chain oversight

  • Strategic procurement

  • Regulatory compliance submissions

  • Systematic technical evaluations

  • Detailed contract review skills

  • Quality inspections

  • Compliance monitoring initiatives

  • QMS implementation expertise

  • Compliance with EU standards

  • Experience with FDA compliance processes

  • WHO guidelines adherence

Certification

01/01/24, Advanced Strategic Management & Innovation

Accomplishments

  • CAPSTONE research project on 'Removing Human Barriers to foster Innovation' as part XLRI Jamshedpur EDP certification is Strategy and Innovation.
  • 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 on Enzymology and Protein Chemistry.
  • GATE 94 cleared.
  • Trained on Regulatory guidelines and IPR Topics.
  • Nominated and completed the Finance and Outbound Training Program for leadership at Ranbaxy Labs.
  • Course in Basic Finance and Outbound training program at Ranbaxy Labs.
  • Training on Project Management, Advanced EXCEL.

Skills - Niche Capabilities

  • Pharma Operations and Business: Active Pharmaceutical Ingredients (APIs), Complex injectable formulations, Biosimilars, Vaccines, Fermentations and Downstream Unit operations, Mammalian Cell culture techniques & Novel Drug Delivery systems and Project Management.
  • Project Commissioning & Commercialization: Commissioning and commercialization of green fields projects. Project Management of Pharmaceutical projects from start to finish.
  • Automation & Technology Transfer: Technology absorption, transfer, scale up and validation from lab to Plant along with designing strategies for Cleaning Validation and automation of systems and procedures.
  • Injectables expertise: Commissioning of Complex injectables plant, Designing Media fills strategies and sterile formulations in semi-automated and fully automated systems.
  • Fostering Innovation culture at site through new initiatives as part of operational excellence, continuous improvements and Cost optimization programs.
  • Contract Manufacturing Businesses: Development of Contract manufacturing sites starting from Identifications to running CMO business.
  • 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, EU, USFDA and WHO Compliance Readiness.

Timeline

Executive Program in Senior Management - Pursuing

Indian Institute of Management (IIM)
06.2024 - 06.2025

Executive Development Program - Strategy and innovation

XLRI
04.2023 - 01.2024

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

Post Graduate Diploma in Biotech Business Management - undefined

Bioinformatics’ Institute of India
06.2005 - 01.2007

Asst Manager - Production

Wockhardt Ltd
10.2004 - 06.2007

Asst Manager - Production

RPG life sciences
09.1999 - 10.2004

Senior Officer - Production

Rallis India Ltd
03.1997 - 09.1999

M Tech - Biotechnology

Jadavpur University
11.1994 - 06.1996

MSc - Biotechnology

GND University
09.1992 - 09.1994

BSc - Chemistry (Honours)

University of Delhi (DU)
07.1989 - 08.1992
Rabin Kumar SurchaudharyPharmaceutical Business