VIKAS NAKHATE
APPLICATION SPECIALIST
Pune,Maharashtra
Summary
Experienced Application Specialist with prior experience as MSAT Assistant Manager and R&D-Associate Engineer with over 8 years of experience in Bio-Pharmaceutical Industry for R&D, MSAT,Manufacturing & Application services . Diligent and meticulous professional commended for quickly and accurately learning new procedures. Excellent reputation for Product Process development, Resolving problems,Technology transfer of projects (R&D to Mfg). Specialized in Process improvement, Data Analysis and Process, Deviation closure, Troubleshooting and driving overall operational improvements. Motivated to learn,grow and excel in Industry.
Overview
8
8
years of professional experience
6
6
years of post-secondary education
2
2
Languages
Work History
APPLICATION SPECIALIST
SARTORIUS STEDIM INDIA PVT. LTD.
PUNE Maharashtra
09.2021 - Current
- Responsible for design and planning exercises for Virus filtration & Clearance services, Clarification and TFF projects for key account groups in India.
- Collaborated with multidisciplinary clients teams to design and implement downstream purification technology in customer processes.
- Involved in 3 major lead generation of Virus filtration by delivering Virus filtration portfolio to customer in India
- Delivered support training to help customers learn key features of Downstream applications.
- Devised technical strategies, created system designs and developed presentation materials for applications.
MSAT ASSOCIATE
DR. REDDYS LABORATORIES HYDERABAD
HYDERABAD
05.2018 - 09.2021
- Execution management of experiments related to Product Process development & Manufacturing of Biosimilar medicine
- Data Analysis (Statistical) for Continuous Process improvement in Biosmilar drug process development.
- Closed multiple Manufacturing deviations, CAPA as part of QMS in MSAT group
- Delivered smooth technology transfer (1 mab and 1 fusion protein) within stipulated timeline.
- Data Mining, Data Visualization (with multiple visualization tools), Component Analysis ,Predictive Analysis (for large scale Data) and Statistical tool implementation for large scale process improvement
- Prepared document viz., IPCM, CPV and Summery report etc.
- Cross-Functional team interaction and Coordination for improved Technology and Product operations.
- Planning, execution and coordination of Tech-transfer and Process fitment of mab molecules (Subcutaneous and I.V. molecule) (Scale : 1 kL in Single used Facility)
Associate Egineer
Intas Biopharmaceuticals
Ahmedabad
07.2015 - 04.2018
- Responsible for Screening and Process development execution experiment for Biosimilar product Development.
- Involved in 2 Process development and 1Process intensification for biosimilar products (mab and Fusion protein) produced using mammalian and microbial cell-based system.
- Contributed to 2 Process development and Technology transfer of Biosimilar from R&D to Manufacturing.
- Involved in Troubleshooting of [Purification process related] processes, in CEX, AEX or TFF process of Downstream.
- Report writing for Process development report (PDR) and Technology transfer (TTD) of Biosimilar Product
- Contributed in Cross functional Team meeting for process improvement and Product Development process.
- Mentored 4-Summer Intern, aiding in on boarding process and in as new team player for laboratories.
Education
M. Tech (Bioprocess Engineering) - Chemical Technology
INSTITUTE OF CHEMICAL TECHNOLOGY (formerly UDCT)
Mumbai (Maharashtra) 07.2013 - 07.2015
B. Pharmacy (Pharmaceutical Technology) - Pharmaceutical Technology
GOVERNMENT COLLEGE OF PHARMACY
AMARAVATI 06.2009 - 05.2013
Skills
Product Process Development and Research
Troubleshooting and problem solving
Data Analysis and Presentation
Process Execution
Accomplishments
- Awarded ''Best Debut Application Specialist'' (2021-2022) in Annual Sartorius Sale Meeting
- Presented Poster in BioProcessing India 2014 at ICT Mumbai.
- All India Rank 542 GATE (GPAT) 2013.
- 2nd Position winner IDP (Industry Defined Problem) during Vortex 2013 at ICT Mumbai.Runner Up for 'AVISHKAR-2011' held at Amravati University.
- Presented a Scientific Paper at 63rd Indian Pharmaceutical Congress Bengaluru-2011.
Timeline
APPLICATION SPECIALIST
SARTORIUS STEDIM INDIA PVT. LTD.
09.2021 - Current
MSAT ASSOCIATE
DR. REDDYS LABORATORIES HYDERABAD
05.2018 - 09.2021
Associate Egineer
Intas Biopharmaceuticals
07.2015 - 04.2018
M. Tech (Bioprocess Engineering) - Chemical Technology
INSTITUTE OF CHEMICAL TECHNOLOGY (formerly UDCT)
07.2013 - 07.2015
B. Pharmacy (Pharmaceutical Technology) - Pharmaceutical Technology
GOVERNMENT COLLEGE OF PHARMACY
06.2009 - 05.2013