RAJ KUMAR
Manager Intas Biopharmaceutical
Begusarai
Summary
Results-driven management professional with proven ability to lead teams to success. Strong focus on team building, collaboration, operational efficiency, and achieving measurable outcomes. Known for adaptability and consistently meeting changing organizational needs.
Overview
14
14
years of professional experience
12
12
years of post-secondary education
Work History
Manager
Intas Biopharmaceutical Ltd.
05.2016 - Current
- Have over 12 years of experience in downstream processing of therapeutic proteins in biopharmaceutical industries. Role and responsibilities handled are as
- Preparation & verification of P&ID, BOM, Valve Matrix
- Coordination for Bench Test, Pre FAT, FAT & SAT
- Preparation, Review & Verification of DQ, IQ, & OQ Documents
- Proficient in SOP Preparation, Change Control write-ups preparation and Review of investigation report
- Well versed in protocol and report writing and review associated with downstream processing (Resin Reuse, Intermediate hold, Blank run, Buffer Hold)
- Implementation of Quality Management System.
- Equipment Cleaning Validation
- Co-ordination with internal agencies i.e QA, QC and Maintenance for smooth and Uninterrupted production activities
- Handling E-BMR batch processing on Process-XE software.
- Co-ordination with R&D and other departments for trial batches, clinical trial batches, validation batches for regulatory markets.
- Responsible for preparation, checking and reviewing of batch record and logbook and other manufacturing records.
- Responsible for ensuring preparedness and audit compliance for observations.
- Preparation and review of commissioning, qualifications and validation documents for manufacturing operations
- To execute and complete commissioning, qualifications and validation in new and Existing facility
- Gap analysis on process and equipment for scale up activities
- To identify and eliminate root cause of Failure/deviation on process and equipment, Change control, closure and track implementation of CAPA in manufacturing facilities.
- Facilitate production planning and inventory control and ensure the minimum inventory of materials to keep the production on schedule.
- Carrying out electronic data review for all 21 CFR systems, identifying the gaps and providing compliance to it.
- Carrying out yearly alarm trending for equipment and take necessary action to reduce the critical alarm in future.
- Maximized performance by monitoring daily activities and mentoring team members.
- Providing process related support to automation teams for smooth execution L2 integration and implementation of PASS X EBMR.
- Accomplished multiple tasks within established timeframes.
- Managed and motivated employees to be productive and engaged in work.
- Built high-performing teams through effective recruitment, onboarding, and talent development initiatives.
Executive
USV PVT LTD
12.2013 - 02.2016
- Worked on Biosimilars Production at USV PVT LTD in Downstream Department.
Officer
Sigma Aldrich
08.2013 - 11.2013
- Worked on Packaging of chemicals at Sigma Aldrich
Junior Executive
Biocon Limited
07.2011 - 08.2013
- Worked in downstream manufacturing of Filgrastim and Peg-Filgrastim at Biocon limited Bangalore.
Education
Master of Science - Biotechnology
Bangalore University
Bangalore, Karnataka 04.2001 - 01.2013
B.SC - Biotechnology
Bangalore University
Bangalore, KarnatakaSkills
Operations management
Decision-making
Team leadership
Project management
Cross-functional teamwork
Personal Information
- Total Experience: 12 years 08 months
- Date of Birth: 02/10/91
- Nationality: Indian
- Marital Status: Married
Timeline
Manager
Intas Biopharmaceutical Ltd.
05.2016 - Current
Executive
USV PVT LTD
12.2013 - 02.2016
Officer
Sigma Aldrich
08.2013 - 11.2013
Junior Executive
Biocon Limited
07.2011 - 08.2013
Master of Science - Biotechnology
Bangalore University
04.2001 - 01.2013
B.SC - Biotechnology
Bangalore University
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