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Sterility Assurance SME · Gent, Belgium · CAR-T & ATMP · Sterility Expert from India

Palash Chandra Das

Sterility Assurance Expert & Sterilization SME  ·  Aseptic Processing & Contamination Control Specialist  ·  Author  ·  Founder, PRES

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About

Engineering Sterility.
Advancing Pharmaceutical Innovation.

I am an M.Pharm professional and sterility assurance SME based in Gent, Belgium, with 15+ years of expertise in sterility assurance, contamination control strategy, aseptic processing, and terminal sterilization. As a sterility expert originally from India, I bring a global perspective to advanced therapy manufacturing — including CAR-T and ATMP production.

My career has spanned MSAT Global R&D and plant roles across sterile injectables (liquid and lyophilized), oncology injectables, bacterial vaccines, and cutting-edge cell therapies — always at the intersection of science, quality, and patient safety.

I am the founder of PRES — Pharmaceutical Resource & Education Services — a voluntary, non-profit platform providing free knowledge to pharmaceutical professionals worldwide. Associate member of the Parenteral Drug Association (PDA).

Regulatory Audit Exposure
USFDA WHO EMA / EU GMP MHRA TGA PMDA-Japan ANVISA-Brazil INVIMA-Colombia CDSCO-India South Korea Germany Ukraine Russia Iran
Sterile Manufacturing: Liquid & Lyophilized
CAR-T & ATMP Manufacturing (J&J collaboration)
Oncology Injectables & Bacterial Vaccines
13+ Global Regulatory Inspection Bodies
Published Author & PDA Technical Report Co-Author
AI Applications in Pharmaceutical QA
Founder — PRES (pres.net.in) & YouTube @cGMP
PDA Associate Member & Conference Speaker
Career Journey

15+ Years of Global Excellence

Feb 2026 — Present
Legend Biotech  |  Gent, Belgium
Sr. Process Engineer – Sterilization (MSAT)
CAR-T Manufacturing · Collaboration with J&J Innovative Medicine
Small Volume Parenteral · CAR-T
Sept 2019 — Jan 2026
Baxter International  |  India → Belgium
Principal Engineer – Sterility Assurance (MSAT R&D)
India (2019–2022)  →  Braine-l'Alleud, Belgium (Mar 2022 – Jan 2026)
Large & Small Volume Parenteral
Sept 2014 — Sept 2019
Dr. Reddy's Laboratories Ltd.  |  India
Qualification & Validation Engineering & IT/CSV Systems (MSAT)
ONCO Injectables · Oral Solid Dosage
June 2013 — Aug 2014
Immacule Life Sciences Pvt. Ltd.  |  India
Qualification & Validation Engineering & IT/CSV Systems (MSAT)
General Injectables · Liquid & Lyophilized
Jan 2011 — Jun 2013
Zydus Cadila Healthcare Ltd.  |  India
Process Engineer – R&D Production
Bacterial Vaccine Injectable · Liquid & Lyophilized
June 2010 — Dec 2010
Pharmenza India Pvt. Ltd.  |  India
In-Process Quality Assurance (IPQA)
Oral Solid Dosage · Liquid Syrup
Core Expertise

Specializations & Skills

Sterility Assurance
Aseptic Processing
Lyophilization
Terminal Sterilization (Moist Heat)
Contamination Control Strategy
ATMP & CAR-T Manufacturing
Qualification & Validation (FAT/SAT/IQ/OQ/PQ)
Equipment Commissioning & Qualification
Environmental Monitoring & Trending
Risk Management (ICH Q9)
Regulatory Compliance & Audit Readiness
AI for Pharmaceutical QA
PRES — Pharmaceutical Resource & Education Services

Sharing Knowledge Freely

🌿 Voluntary · Non-Profit · Free

"Knowledge is not something to be kept — it is something to be shared."

PRES started with a simple thought: the belief that sharing pharmaceutical knowledge is one of the most valuable ways to serve society. Even in today's world, where information seems to be at everyone's fingertips, people still struggle to access reliable knowledge or engage in meaningful discussion.

PRES was my response to that gap — a platform where pharmaceutical resources are freely available, with no cost attached, so that anyone — whether a professional or a curious learner — can benefit. This is a voluntary, non-profit initiative I run alongside my professional work.

I bring to it 15+ years of experience as a sterility assurance subject matter expert in sterile medicines manufacturing — aseptic processing and terminal sterilisation. By contributing freely through PRES, I hope to support professionals, encourage open discussion, and play a small role in making healthcare safer for all.

Publications & Authorship

Contributions to Science

Sterility Assurance Essentials
Practical Guide for Beginners to Intermediate Professionals

Volume 1: Fundamentals and Regulatory Expectations
Palash Chandra Das · July 2026
Self-Published · Volume 1 · Fundamentals & Regulatory Expectations

Sterility Assurance Essentials

A comprehensive practical guide for GMP professionals at the early-to-intermediate stage of their pharmaceutical careers. Written in plain language with real-world examples — bridging theory with practical GMP application in modern sterile manufacturing environments, referenced against EU GMP Annex 1 (2022), EMA guidelines, ICH Q9/Q10, and international standards.

EU GMP Annex 1 (2022) Contamination Control Aseptic Processing Sterilization Science EMA Guidelines ICH Q9 / Q10 Environmental Monitoring July 2026
PDA Technical Report · Co-Author
Point to Consider No.14: Manufacturing of ATMPs — Facility Design (Part 1)
Parenteral Drug Association (PDA) · Co-authored with global industry experts · Covers facility design considerations for Advanced Therapy Medicinal Products manufacturing.
Published: December 1, 2025
Academic · M.Pharm
Master's in Pharmacy — Pharmaceutical Medicinal Chemistry
1st Class · West Bengal University of Technology (WBUT), Kolkata, India · Specialized in pharmaceutical medicinal chemistry, providing the scientific foundation for sterility assurance expertise.
2008 – 2010 · WBUT, Salt Lake City, Kolkata
Speaking & Knowledge Sharing

Thought Leadership & Education

Emerging Trends in Sterility Assurance

Presented on cutting-edge developments and technologies shaping the future of sterility assurance in sterile manufacturing environments.

3rd Annual Aseptic Processing Forum · Berlin, 28–29 May 2024

Regulatory Landscape 2024: Sterilization & Disinfection

Navigating new international standards in sterilization and disinfection — covering the latest regulatory updates from EMA, USFDA, WHO, and regional authorities.

Pharma Microbiology Congress 2024 · Virtual, 28–29 Oct 2024

PRES Knowledge Platform

Founder of pres.net.in — a voluntary, non-profit hub with interactive calculators, GMP simulators, quizzes, and in-depth technical guides for pharmaceutical professionals at no cost.

Ongoing · pres.net.in · Est. 2019

YouTube — PRES @cGMP Education

Educational video content covering EU GMP Annex 1, sterility testing, validation science, lyophilization, and regulatory guidance — empowering early-career GMP professionals globally.

YouTube · PRES Channel · Ongoing
Let's Connect

Get in Touch

Open to collaborations, speaking invitations, consulting opportunities, and conversations about sterility assurance, CAR-T manufacturing, ATMP, and pharmaceutical knowledge-sharing globally.

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Based in Belgium

Gent · Belgium

Sr. Process Engineer – Sterilization
Legend Biotech (CAR-T, J&J collaboration)

Belgian D-Visa valid to 2028 · Indian National
Languages: English, Bengali, Hindi

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