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Gursharanjit Singh Shinh

@gursharanjitsinghshi

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Seasoned pharmaceutical manufacturing leader driving operational excellence.

India

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What I'm looking for

I seek a senior leadership role in a growth-driven pharmaceutical company, focused on driving operational excellence, regulatory compliance, digital transformation and mentoring high-performing teams to deliver successful global product launches.

I am a pharmaceutical manufacturing leader with 18 years of progressive experience across OSD, semi-solids, injectables and potent molecules, leading manufacturing operations, MSAT, formulation development and global tech transfers.

As Unit Head – Manufacturing Operations at Dr. Reddy’s (FTO-8), I led 130+ team members, delivered 25+ tech transfers and 30+ new product launches, implemented Pas-X MES and lean initiatives, and achieved zero-observation audits across USFDA, WHO, EU, Russia and Ukraine.

I am passionate about talent development, digital transformation and GMP-driven operational rigor, and I bridge science and operations as a certified OPSNext Business Translator to drive sustainable site performance and compliant product launches.

Experience

Work history, roles, and key accomplishments

Unit Head Manufacturing

Dr. Reddy's Laboratories

Apr 2018 - Oct 2025 (7 years 6 months)

Lead end-to-end manufacturing operations for FTO-8, driving production planning, tech transfers and GMP-ready launches; delivered 25+ tech transfers, 30+ product launches and achieved zero-observation audits across USFDA, WHO and EU while leading 130+ staff.

Manufacturing Operations PAS X MES OSD Semi Solid Injectables

Associate Scientific Manager

Biocon

Mar 2011 - Apr 2018 (7 years 1 month)

Led formulation development, scale-up and tech transfers for OSD and semi-solid products, interfacing between R&D and manufacturing to enable commercial launches and CMO transfers for regulated markets.

Scaling Process Optimization Potent Molecules Regulatory Submissions

Research Associate

Strides Arcolab

May 2010 - Mar 2011 (10 months)

Developed and scaled oral oncology formulations for US and EU dossiers, managed exhibit/pre-exhibit batches and supported regulatory filings for ANDAs.

Scaling Dossier Containment Isolator Handling Process Standardization

Research Officer

Glenmark

Sep 2008 - Apr 2010 (1 year 7 months)

Formulated and scaled oral oncology products for regulated markets, managed pre-exhibit batches and supported regulatory submissions to enable ANDA progression.

Oncology Scaling Regulatory Process Optimization

Research Associate

Cadila Pharma

Aug 2007 - Sep 2008 (1 year 1 month)

Developed NDDS formulations including OSD and injectable concepts, executed scale-up and optimization batches for domestic and ROW markets improving process robustness.

OSD Scaling Troubleshooting Process Optimization Liposomal Formulations

Education

Degrees, certifications, and relevant coursework

Rajiv Gandhi University of Health Sciences

Master of Pharmacy, Pharmaceutical Technology

2006 - 2007

Grade: 75.35%

Activities and societies: Academic project: Comparative Study on Iontophoresis and Passive Permeation using Model Drugs; publication in AAPS PharmSciTech.

Completed Master of Pharmacy in Pharmaceutical Technology with a focus on formulation and transdermal delivery research.