Jagdish Shinde
Hyderabad
Summary
Looking forward to be a part of a dynamic organization driven by excellence and innovations to which i can impart my technical knowledge and managerial skills.
Overview
10
10
years of professional experience
6
6
years of post-secondary education
Work History
Manager - CuraTeq Biologics Pvt Ltd
CuraTeq Biologics Pvt Ltd
04.2021
- Subject Matter Expert (SME) from Manufacturing to explaining to EMA auditor during facility round, Cleaning Validation, Deviation and Batch Manufacturing Record
- Provide training and conduct assessments
- Preparation of the document in eDMS , TMS System
- Experience in designing of process intermediates and buffer hold time study and preparation of protocol
- Handling of QMS documents e.g
- Change control, Deviation, CAPA, OOS and their closing reports with scientific rationale and with effective investigation
- Preparation and review of protocol and report of Cleaning validation and process performance qualification (PPQ)
- Handled single use disposable bag for the buffer and in process material storage
- Experience to prepare and review of cGMP documents i.e
- Risk assessment report, Summary report, justification report and Cleaning validation protocol, MFR and BMR
- Involved in designing and Qualifications (FAT, UAT) of eBMR,eDMS Experience of performing the Audit trial review of the equipment
- Good Process understanding and verse with the unit operations such as clarification by depth filtration , concentration by TFF, purification by chromatography and final DS sterile filtration Timely support to the team members and troubleshooting during the execution of the batches and Performance verification of equipment.
Deputy Manager - Serum Institute of India Private Ltd
Serum Institute of India Private Ltd
08.2012 - 03.2021
- I worked 8.5 years in Serum Institute of India pvt ltd
- On Purification of HbsAg Surface antigen purification step Good Process understanding and verse with the unit operations such as cell concentration and clarification by continuous centrifuge, cell lysis, clarification by depth filtration
- Involved in Qualification of CIP Machine and up gradation of system to comply with 21 CFR parts 11
- Involved in annual cleaning verification of all DSP product contact equipment
- Involved in SOP Preparation in eDMS Initiation, Implementation and closure of change control on a timely manner
- Involved in facility readiness and during the audit.
Research Associate - Celestial Biological (Intas Biopharma Ahmedabad)
Celestial Biological (Intas Biopharma Ahmedabad)
03.2011 - 08.2012
- Optimization of Plasma Fractionation (Precipitation Step) Optimization and scale up of Chromatography Optimization and scale up of Tangential Flow Filtration
- Optimization and scale up of clarification and concentration step by using Hollow Fibre and Plate and frame filter
- Handling- AKTA- prime, Basic, purifier and Pilot
- Equipment/Instrument Handled: Experience in handling of BPG column, and Quick Scale column for AEX, CEX , HIC and mixed mode chromatography
- CIP SKID, Product Hold Vessel, Media Preparation Vessel
- Sartorius single use mixer and product hold bag of 1000L , 650L, 500 L, 200L, 50L, 20L and 10 L
- Continuous centrifuge (Westfalia CSC 6) Roller Ball Mill (DYNO-MILL KD 20) Experience to operate Automated TFF System (Sartorious) Experience to operate Sartoflow advance and Smart TFF System (Sartorious) Experience to operate AKTA Pilot and NOVASEP Chromatography system
- Experience to operate automated process vessel control through SCADA
- Experience to operate automated CIP system Handling of UV Visible Spectrophotometer and HPLC Audit Faced EMA CDSCO WHO
Education
M Tech - Bioprocess Technology
Institute of Chemical Technology
Matunga Mumbai 06.2008 - 06.2010
B. Pharma - Pharmacy
RGUHS
Bangalore 09.2003 - 12.2007
Education Qualifications
- M.Tech (Bioprocess Technology), June 2010, UDCT Mumbai, 60
- B.Pharm, Dec 2007, RGUHS Bangalore, 69
- H.S.C, Mar 2003, Nasik Divisional, 69
- S.S.C, Mar 2001, Nasik Divisional, 72
Academic Achievements
- Awarded Department of Biotech DBT Fellowship for year 2008-2010
- Qualified GATE 2008 with All India Rank 170
Personal Attributes
- Good Communication
- Negotiation Skill
- Strong relationship builder for long lasting
- Have team leading and team management ability.
- Diligence and tendency towards pursuits of problem till end.
- Independent work skill and very quick learner.
- Have Positive Team oriented attitude.
Software Skills
Microsoft Office
References
Available on request
Cover Letter
This application is to express my interest for a suitable position in your esteemed organization. I have 13 year’s experience in manufacturing department. I am currently working in CuraTeq Biologics Pvt Ltd. as a Manager in Bio bulk manufacturing department since April 2021. In CuraTeq I am handling the product Peg-GCSF, Ranibizumab. Before CuraTeq, I worked 8.5 years in Serum Institute of India pvt ltd. In SIIPL I worked on Purification of HbsAg Surface antigen. Expertise in downstream unit operation. Exposure to handle of recombinant proteins and bio-therapeutics projects in cGMP area. Sound knowledge and awareness of cGMP controls, quality management systems and regulatory aspects. Prepare cGMP documents related to facility, process and products supplies to regulated markets. As an area lead, working with 12 members team of Downstream. I am presently looking for a position where my experience will make a positive contribution to the continuing profitable operations of a business.
Place
Jagdish Shinde
Personal Information
- Date of Birth: 10/30/85
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Disclaimer
I hereby declare that, the information furnished above is true to the best of my knowledge and belief.
Timeline
Manager - CuraTeq Biologics Pvt Ltd
CuraTeq Biologics Pvt Ltd
04.2021
Deputy Manager - Serum Institute of India Private Ltd
Serum Institute of India Private Ltd
08.2012 - 03.2021
Research Associate - Celestial Biological (Intas Biopharma Ahmedabad)
Celestial Biological (Intas Biopharma Ahmedabad)
03.2011 - 08.2012
M Tech - Bioprocess Technology
Institute of Chemical Technology
06.2008 - 06.2010
B. Pharma - Pharmacy
RGUHS
09.2003 - 12.2007
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