Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Languages
References
Timeline
Generic

VENKATESAN R

Chennai

Summary

Successfully managed technical and project management aspects of product transfer within stipulated timelines, with a milestone of 5 products site transferred in 2.5 years.
Experienced site-to-site and external transfer of over 20 products, including injectables, solid oral, liquid oral, and semi-solid dosage forms. Proficient in driving cost-effective and timely PLCM changes. Adept in overcoming hurdles and delivering results.

Overview

12
12
years of professional experience
1
1
Certification

Work History

Manager - Technology Transfer

Pfizer
Chennai
06.2022 - Current
  • Overseeing the transfer of late-stage development or commercial manufacturing processes for drug products.
  • Provide technical guidance to process validation and development for new processes.
  • Identify and implement process optimization initiatives and communicate CMOs performance regularly to management.
  • Provide scientific direction for problem-solving and root cause analysis at Drug Product CMOs.
  • Oversees the transfer of late-stage development or commercial manufacturing processes for drug products.
  • Develops Technology Transfer plans and ensures global standards and governance are applied.
  • Ensures Technology Transfer best practices are adhered to and performs gap analysis.
  • Constructs Technology Transfer plans and ensures effective collaboration and communication between sending and receiving sites.
  • Oversees all activities identified for every phase of a TT project and ensures technical documentation delivered OTIF.
  • Prepares lessons learned from executed transfers and ensures proper closure of Technology Transfer projects.

Team Leader

Apotex India (ARPL)
Bangalore
09.2017 - 06.2022
  • Worked as Assistant Manager in Global External Supply Operations.
  • Performed due diligence on CMO plants and review MSA and costing.
  • Responsible for project planning, milestone tracking, risk management, and ensuring document availability.
  • Conduct meetings with stakeholders, mitigate risks, and collaborate as a team member.
  • Lead technology transfer, scientific experimentation, and managing process validation and packaging validation strategies to meet cGMP and quality requirements.

Sr. Executive

Strides Shasun Ltd
Bangalore
03.2015 - 09.2017
  • Handled Oral Liquids & Semi-Solids scale up & transfer for exhibit batch (Market:US)
  • Review of tech packs, gap analysis, risk assessment, trial reports, LNB, and BMR.
  • Review of process validation protocol report; Exhibit batch report.
  • Conducting meetings and coordination with CFT & external customers for initiation smooth execution of new products.
  • Execution of PO, Pre-Exhibit, Exhibit, Process validation batches, and manpower handling for timely execution.
  • Addressing deficiencies & information request from agencies.
    Initiation, investigation, and closure of change control and deviations (Trackwise).
  • Qualification activities:
    Preparation of URS.
    Involved in OQ & PQ of equipment.
    Review of SOP of the equipment
    Following equipments qualification experience.
    IGS Glatt – 200L
    Fette 1200i
    Gansons coating machine 600/900

Executive

Kemwell Biopharma Pvt Ltd
Nelamangala, Bangalore
01.2014 - 03.2015
  • Worked as Executive -Technology transfer
  • Solid orals, Liquid orals and Semi-solids
  • MPA and USFDA approved plant.

Officer

Shasun Pharma Ltd
Periyakalapet, Pondy
12.2011 - 01.2014
  • Worked as Officer-Technology transfer at Shasun Pharma LTD, Periyakalapet, Pondy.
  • USFDA, MHRA, TFDA, ANVISA and WHO approved plant.

Education

M.S. (Industrial Pharmaceutics) - Pharmaceutical Sciences

JNTU Hyderabad
Hyderabad
11.2011

B.Pharma - Pharmaceutical Sciences

Annamalai University
Chidambaram
05.2007

Skills

  • Technology transfer
  • Site-Site transfer
  • Contract manufacturing
  • Solids orals (Tablets, Capsules & Softgel)
  • Liquid orals
  • Injectables (DPI, PFS & LVP)
  • Project Coordination
  • Six Sigma Green Belt Certified

Accomplishments

  • 2020 Global Award Winner Apotex Inc.

Certification

  • Six Sigma (Green Belt) From Juran Institute.
  • Master in Project Management

Languages

Tamil
First Language
Telugu
Upper Intermediate (B2)
B2
Kannada
Upper Intermediate (B2)
B2
Hindi
Intermediate (B1)
B1
English
Advanced (C1)
C1

References

References available upon request.

Timeline

Manager - Technology Transfer

Pfizer
06.2022 - Current

Team Leader

Apotex India (ARPL)
09.2017 - 06.2022

Sr. Executive

Strides Shasun Ltd
03.2015 - 09.2017

Executive

Kemwell Biopharma Pvt Ltd
01.2014 - 03.2015

Officer

Shasun Pharma Ltd
12.2011 - 01.2014

M.S. (Industrial Pharmaceutics) - Pharmaceutical Sciences

JNTU Hyderabad

B.Pharma - Pharmaceutical Sciences

Annamalai University

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VENKATESAN R